The Recall Desk

Archive

July 2013 recalls

741 recalls were announced in July 2013.

What the numbers show

Critical
104
Severe
251
High
252
Moderate
109
Low
25

Of the 741 recalls this month scored against our rubric, 14% are Critical, 34% are Severe.

301–400 of 741

  • SevereFDA (Drugs)·D-685-2013·2013-07-17

    Fresenius Kabi Recalls Benztropine Mesylate Injection Due to Glass Particulates

    Fresenius Kabi is recalling 65,110 vials of Benztropine Mesylate Injection due to the presence of glass particulate matter. The affected vials were distributed nationwide and in Puerto Rico.

    Product
    BENZTROPINE MESYLATE — BENZTROPINE MESYLATE (BENZTROPINE MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-753-2013·2013-07-17

    Olympia Pharmacy Recalls Metabolase Forte Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Metabolase Forte Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Metabolase Forte Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-741-2013·2013-07-17

    Olympia Pharmacy Recalls Hippiron Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of Hippiron 20 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Hippiron 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-788-2013·2013-07-17

    Olympia Pharmacy Recalls Tripelennamine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of compounded Tripelennamine 20 mg/ml Injection due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Tripelennamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-752-2013·2013-07-17

    Olympia Pharmacy Recalls Meloxicam Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Meloxicam 5 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Meloxicam 5 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-755-2013·2013-07-17

    Olympia Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Methylcobalamin P 10/ml Creatine 40 mg/ml / Arginine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-699-2013·2013-07-17

    Olympia Pharmacy Recalls Aminocaproic Acid Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Aminocaproic Acid 0.5mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Aminocaproic Acid 0.5mg/ml Injection,compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-747-2013·2013-07-17

    Olympia Pharmacy Recalls L-Arginine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling L-Arginine 200 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    L-ArGiNINE 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-732-2013·2013-07-17

    Gentamicin Injection Recalled for Lack of Sterility Assurance

    Olympia Pharmacy is recalling Gentamicin 0.3% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Gentamicin 0.3% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-730-2013·2013-07-17

    Olympia Pharmacy Recalls Furosemide Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Furosemide 50 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Furosemide 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-782-2013·2013-07-17

    Olympia Pharmacy Recalls Sodium Tetradecyl Sulfate Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling specific lots of compounded Sodium Tetradecyl Sulfate injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Sodium Tetradecyl Sulfate (0.125%, 1%, 2.5%, 3%, and 4%) Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-761-2013·2013-07-17

    Olympia Pharmacy Recalls Miconazole Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Miconazole 3% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Miconazole 3% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-701-2013·2013-07-17

    Olympia Pharmacy Recalls Atipamezole Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Atipamezole 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-760-2013·2013-07-17

    Olympia Pharmacy Recalls MICC Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling MICC and MICC 25/50/330 injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 25/50/330 Inj, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-793-2013·2013-07-17

    Olympia Pharmacy Recalls Vitamin B-Buildup Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Vitamin B-Buildup Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-781-2013·2013-07-17

    Sodium Salicylate Injection Recalled for Sterility Concerns

    Olympia Pharmacy is recalling Sodium Salicylate 40% Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Sodium Salicylate 40% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-724-2013·2013-07-17

    Olympia Pharmacy Recalls Disodium EDTA Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Disodium EDTA Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Disodium EDTA Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-698-2013·2013-07-17

    Aminocaproic Acid Injection Recalled for Sterility Concerns

    Olympia Pharmacy is recalling Aminocaproic Acid 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Aminocaproic Acid 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-734-2013·2013-07-17

    Olympia Pharmacy Recalls Gentamicin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Gentamicin 80 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Gentamicin 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-725-2013·2013-07-17

    Olympia Pharmacy Recalls Doxapram Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Doxapram 20 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Doxapram 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-728-2013·2013-07-17

    FDA Recalls Compounded Estradiol and Testosterone Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling compounded Estradiol Cypionate and Test Cyp injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Estradiol Cypionate 2 mg/ml Test Cyp 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-742-2013·2013-07-17

    Olympia Pharmacy Recalls Idoxuridine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Idoxuridine 0.1% Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Idoxuridine 0.1% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-779-2013·2013-07-17

    Olympia Pharmacy Recalls Sermorelin/GHRP Vials Due to Sterility Concerns

    Olympia Pharmacy is recalling Sermorelin/GHRP vials because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Sermorelin/GHRP 3 mg/3 mg vial, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-769-2013·2013-07-17

    Olympia Pharmacy Recalls Phenobarbital Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Phenobarbital 62.5 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Phenobarbital 62. 5mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1698-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 30 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-735-2013·2013-07-17

    Gentamicin Sulfate Injection Recalled for Sterility Concerns

    Olympia Pharmacy is recalling Gentamicin Sulfate 80 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Gentamicin Sulfate 80 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-773-2013·2013-07-17

    Olympia Pharmacy Recalls Polidocanol Injections Due to Sterility Concerns

    Olympia Pharmacy is recalling Polidocanol injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-697-2013·2013-07-17

    Olympia Pharmacy Recalls Amikacin Sulfate Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Amikacin Sulfate 250 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-726-2013·2013-07-17

    Olympia Pharmacy Recalls Enrofloxacin Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Enrofloxacin 20 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    Enrofloxacin 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-767-2013·2013-07-17

    Olympia Pharmacy Recalls Pento-Gluc Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Pento-Gluc 200 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Pento-Gluc 200 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1604-2013·2013-07-17

    Finger Lakes Farmstead Bier Meck Gouda Recalled for Listeria

    Finger Lakes Farmstead Cheese Company is recalling 7 wheels of Bier Meck Gouda due to Listeria monocytogenes contamination.

    Product
    Finger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGENT ROAD TRUMANBURG, NY Ingredients: raw milk, rennet, calcium chrloride, cultures, beer, salt
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1699-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-713-2013·2013-07-17

    Olympia Pharmacy Recalls Chlorpromazine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of compounded Chlorpromazine HCL 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Chlorpromazine HCL 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-700-2013·2013-07-17

    Olympia Pharmacy Recalls Aminophylline Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Aminophylline 2.5% Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Aminophylline 2.5% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-727-2013·2013-07-17

    Olympia Pharmacy Recalls Estradiol Cypionate Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Estradiol Cypionate 10 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Estradiol Cypionate 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-714-2013·2013-07-17

    Olympia Pharmacy Recalls Clenbuterol Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Clenbuterol 0.03mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Clenbuterol 0.03mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-746-2013·2013-07-17

    Olympia Pharmacy Recalls Ketoprofen Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Ketoprofen Solution 10% Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1605-2013·2013-07-17

    Garden Highway Island Medley Fresh Fruit Recalled for Salmonella Risk

    GHSW, LLC is recalling Garden Highway Island Medley fresh fruit due to potential Salmonella contamination from mangoes sourced from Agricola Daniella.

    Product
    Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Island Medley Net Wt. 1 lb (454g) Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Pineapple, Mango, Papaya Packed in its own juice, UPC Code: 826766201044
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-717-2013·2013-07-17

    Olympia Pharmacy Recalls Detomidine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling two lots of Detomidine 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Detomidine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-715-2013·2013-07-17

    Cre-O-Pan Injection Recalled Due to Sterility Concerns

    Olympia Pharmacy is recalling Cre-O-Pan Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Cre-O-Pan Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-745-2013·2013-07-17

    Olympia Pharmacy Recalls Ketamine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Ketamine 100 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Ketamine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-710-2013·2013-07-17

    Olympia Pharmacy Recalls Calcium Gluconate Due to Sterility Concerns

    Olympia Pharmacy is recalling Calcium Gluconate 23% because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Calcium Gluconate 23%, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-750-2013·2013-07-17

    Olympia Pharmacy Recalls Medetomidine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Medetomidine 2 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Medetomidine 2 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1685-2013·2013-07-17

    Integra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage

    Integra LifeSciences is recalling Hallu-Fix cannulated screw drivers and tips because the tips have been reported to break during surgery.

    Product
    Integra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-703-2013·2013-07-17

    Olympia Pharmacy Recalls Beta Alanine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Beta Alanine and L-Carnosine injections because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Beta Alanine 100 mg/ml / l-carnosine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-768-2013·2013-07-17

    Olympia Pharmacy Recalls Pentosan Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling three vials of compounded Pentosan 250 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Pentosan 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-796-2013·2013-07-17

    Olympia Pharmacy Recalls Yohimbine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Yohimbine 10 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    Yohimbine 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-708-2013·2013-07-17

    Olympia Pharmacy Recalls Buprenorphine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Buprenorphine 0.3 mg/ml Injection because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1608-2013·2013-07-17

    GHSW LLC Recalls Mango Spears for Potential Salmonella Contamination

    GHSW, LLC is recalling Garden Highway and Winn-Dixie brand mango spears in Florida, Louisiana, and Texas due to potential Salmonella contamination.

    Product
    Mango Spears: 1) Garden Highway Fresh Fruit Perishable Keep Refrigerated Mango Spears Net Wt 1 LB (454g) Renaissance Food Group LLC ,Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Mango Packed in its own juice; UPC: 826766268498 2) Mango Spears 1 lb (454g) Ingred
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-712-2013·2013-07-17

    Olympia Pharmacy Recalls Ceftiofur Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Ceftiofur GM vials because FDA inspection findings raised concerns about quality control and sterility assurance.

    Product
    Ceftiofur GM vial 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-729-2013·2013-07-17

    Olympia Pharmacy Recalls Fluphenazine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Fluphenazine 25 mg/ml Injection because FDA inspection findings raised concerns about quality control and assurance of sterility.

    Product
    Fluphenazine 25 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1637-2013·2013-07-17

    Palmer Candy Co Recalls Pistachios for Salmonella Contamination Risk

    Palmer Candy Co is recalling Eagle Premium and Snack Shoppe in-shell pistachios due to potential Salmonella contamination. The product was distributed in six states.

    Product
    Eagle Premium, Snack Shoppe, Pistachios, in-shell pistachios, packaged in 2-oz (UPC 4262500705) and 5.25-oz (UPC 42625000604) bags. Distributed by: Genco Marketing, Omaha, NE.
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Drugs)·D-731-2013·2013-07-17

    Olympia Pharmacy Recalls Compounded Gaba Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling compounded Gaba injections due to FDA inspection findings regarding quality control and sterility assurance.

    Product
    Gaba 50 mg/Mag Sulfate 50 mg/Taurine/Theanine 50 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-718-2013·2013-07-17

    Olympia Pharmacy Recalls Detomidine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Detomidine w/Xylazine Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Detomidine w/Xylazine 100 mg/mg Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-766-2013·2013-07-17

    Olympia Pharmacy Recalls PEN-DEX-CHLOR Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling PEN-DEX-CHLOR Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    PEN-DEX-CHLOR Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1693-2013·2013-07-17

    Fresenius Hemodialysis Machine O-Rings Recalled for Incorrect Material

    Fresenius Medical Care is recalling 725 replacement O-rings for hemodialysis machines because they were made of nitrile rubber instead of the required EPDM material.

    Product
    Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-762-2013·2013-07-17

    Olympia Pharmacy Recalls Naproxen Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Naproxen 100 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-789-2013·2013-07-17

    Olympia Pharmacy Recalls Vitamin 15 Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Vitamin 15 (HEMO15) Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Vitamin 15 (HEMO15) Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1669-2013·2013-07-17

    Cardio Medical Products Defibrillator Electrodes Recalled for Arcing and Sparking

    Cardio Medical Products is recalling 657 defibrillator electrodes due to reports of arcing and sparking on the leadwire.

    Product
    Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-785-2013·2013-07-17

    Olympia Pharmacy Recalls Taurine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Taurine 100 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-749-2013·2013-07-17

    Lisinopril Injection Recalled for Sterility Assurance Concerns

    Olympia Pharmacy is recalling Lisinopril 20 mg/ml Injection due to FDA inspection findings regarding quality control and lack of assurance of sterility.

    Product
    Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1606-2013·2013-07-17

    Garden Highway Fruit Burst Recalled for Potential Salmonella Contamination

    GHSW, LLC is recalling Garden Highway Fruit Burst and Winn-Dixie brand fruit products due to potential Salmonella contamination from mangoes.

    Product
    Fruit Burst, ingredients: Cantaloupe, Pineapple, Honeydew, Watermelon, Red Grapes, Mango, Strawberries, Blueberries: 1) Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated, Net Wts 1 lb, UPC 826766241071 and 1.5 lbs., UPC 826766241279; 2) Fruit Burst Net Wt
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Drugs)·D-772-2013·2013-07-17

    Olympia Pharmacy Recalls Phenylephrine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling Phenylephrine 1 mg/ml Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Phenylephrine 1 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-695-2013·2013-07-17

    Olympia Pharmacy Recalls Alprostadil Due to Sterility Concerns

    Olympia Pharmacy is recalling Alprostadil 2000 mcg/ml because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Alprostadil 2000 mcg/ml, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-711-2013·2013-07-17

    Cal-Phos 1000 Injection Recalled Due to Sterility Concerns

    Olympia Pharmacy is recalling Cal-Phos 1000 Injection because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Cal-Phos 1000 Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-770-2013·2013-07-17

    Olympia Pharmacy Recalls Phentolamine Injection Due to Sterility Concerns

    Olympia Pharmacy is recalling five vials of Phentolamine 20 mg/ml Injection because FDA inspection findings raised concerns about quality control processes and assurance of sterility.

    Product
    Phentolamine 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2013·2013-07-17

    ConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect

    ConMed Linvatec is recalling APEX Arthroscopy Tubing Sets because a scratch on the pressure fitting may cause the irrigation pump to increase fluid flow to the surgical site.

    Product
    ***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-758-2013·2013-07-17

    Methylprednisolone Injection Is Recalled Over Sterility Assurance Concerns

    Olympia Pharmacy is recalling compounded methylprednisolone acetate 80 mg/mL injection, code A3104, expiring June 4, 2013, because FDA inspection findings raised concerns about quality control and sterility assurance. The product was distributed nationwide and in Puerto Rico.

    Product
    Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1628-2013·2013-07-17

    Eco-Cuisine Recalls Cookie Mix Due to Potential Salmonella Contamination

    Eco-Cuisine is recalling 25 lb bags of Cookie Mix because a raw materials supplier reported potential salmonella contamination.

    Product
    Eco-Cuisine Cookie Mix, SKU: CM25COOK, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1650-2013·2013-07-17

    Christian Cheese Sun-Dried Tomato Cheddar Recalled for Undeclared Sulfites

    Christian Cheese, LLC is recalling Sun-Dried Tomato Cheddar cheese due to undeclared sulfites. The product was distributed in Colorado and Oklahoma.

    Product
    Christian Cheese Sun-Dried tomato Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Sun-Dried Tomato and Salt. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 uni
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1620-2013·2013-07-17

    Eco-Cuisine Betty Brownie Mix Recalled for Potential Salmonella Contamination

    Eco-Cuisine is recalling Betty Brownie Mix with Vanilla due to potential salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Betty Brownie Mix with Vanilla, Pack size 1.09 lb bag, 10 bags per case or 25 lbs bulk, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
    Category
    Food
    Distribution
    0 states
  • HighCPSC·13240·2013-07-17

    Thermobaby Bath Seats Recalled by SCS Direct Due to Drowning Hazard

    SCS Direct is recalling Thermobaby Aquababy Bath Ring Seats sold at Amazon.com because they can tip over, posing a drowning risk to babies.

    Product
    Thermobaby Aquababy Bath Ring Seats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1619-2013·2013-07-17

    Los Milagros Green Corn Tamales Recalled for Undeclared Milk Allergen

    Los Milagros Tortilleria is recalling Green Corn Tamales because they contain an undeclared milk allergen from Monterey Jack cheese.

    Product
    Milagros Green Corn Tamales, packaged in plastic in quantities of one dozen
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-707-2013·2013-07-17

    FDA Recalls Compounded Dexamethasone Eye Ointment Over Sterility Concerns

    Olympia Pharmacy is recalling one unit of compounded BNP/dexamethasone eye ointment because FDA inspection findings raised concerns about sterility assurance and quality control. The listed distribution is nationwide and Puerto Rico.

    Product
    BNP/Dexamethasone Eye Ointment, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1700-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement between bone and the poly bearing.

    Product
    REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1599-2013·2013-07-17

    Salmolux Recalls Cold Smoked Salmon for Potential Listeria Contamination

    Salmolux is recalling specific cold smoked salmon products due to potential Listeria monocytogenes contamination. Consumers in ten states should check their refrigerators for these items.

    Product
    ATLANTIC SALMON: 1) "***Raley's***NOVA LOX***NET WT 4 OZ (113 g)***INGREDIENTS: ATLANTIC SALMON (FARM RAISED-COLOR ADDED), SALT, SUGAR, SODIUM NITRITE, NATURAL WOOD SMOKE. CONTAINS: SALMON (FISH)***READY TO EAT***REFRIGERATED BELOW 38F***Proudly Distributed By: Raley's, 500 W
    Category
    Food
    Distribution
    10 states
  • HighFDA (Devices)·Z-1673-2013·2013-07-17

    Boston Scientific Recalls NephroMax Balloon Catheter Kits Due to Packaging Error

    Boston Scientific is recalling 15 NephroMax high pressure nephrostomy Balloon Catheter Kits because an incorrectly sized renal sheath was packaged with the device.

    Product
    NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2013·2013-07-17

    Baxter Elastomeric Infusion Pumps Recalled for Leakage at Luer Connection

    Baxter Healthcare is recalling specific lots of elastomeric infusion pumps due to reported leakage at the blue winged cap connection after storage.

    Product
    Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for sl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-778-2013·2013-07-17

    Olympia Pharmacy Recalls Quadmix Due to Sterility Concerns

    Olympia Pharmacy is recalling three lots of Quadmix because FDA inspections raised concerns about quality control and sterility assurance.

    Product
    Quadmix, compounded by Olympia Pharmacy, Orlando, FL
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1600-2013·2013-07-17

    Salmolux Recalls Cold Smoked Salmon Due to Listeria Risk

    Salmolux is recalling specific varieties of cold smoked salmon due to potential contamination with Listeria monocytogenes.

    Product
    KETA SALMON: 1) "***ALASKAN SMOKED SALMON (NOVA LOX)***Net WT. 16 oz (454g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44294 8***". 2) "***WILD KETA SMOKED SALMON (NOVA LOX) TRIM
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-1657-2013·2013-07-17

    Torn & Glasser Recalls Pistachios Due to Salmonella Contamination Risk

    Torn & Glasser Inc. is recalling specific brands of roasted and salted pistachios because they may be contaminated with Salmonella. The affected products were distributed in California, Arizona, and Hawaii.

    Product
    Roasted and Salted Pistachios packed under the following brand names and packaging: Sprouts Brand Roasted & Salted Pistachios, various weights. into 12 individual plastic bags with various weights per unit, then packaged into 10 lbs cardboard box. . Sun Harvest Brand Roaste
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1696-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.

    Product
    REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-1630-2013·2013-07-17

    Eco-Cuisine Basic Pancake Mix Recalled for Salmonella Contamination

    Eco-Cuisine is recalling Basic Pancake Mix due to potential Salmonella contamination reported by a raw materials supplier.

    Product
    Eco-Cuisine Basic Pancake Mix, SKU: TV25PANC, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1704-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw

    Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone impingement during full knee extension.

    Product
    REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1714-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.

    Product
    REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1716-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1702-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 23 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1723-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1719-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 31 units of Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.

    Product
    REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1715-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1694-2013·2013-07-17

    Siemens Mammomat Inspiration Mammography Systems Recalled for Potential Malfunction

    Siemens is recalling three Mammomat Inspiration mammography systems due to a potential malfunction that could cause patient bruising during specific imaging procedures.

    Product
    Siemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1709-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Implants

    Biomet is recalling 20 Oxford Fixed Bearing Partial Knee implants due to a design defect that may cause anterior impingement between bone and the poly bearing component.

    Product
    REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1712-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Components

    Biomet is recalling 46 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.

    Product
    REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1722-2013·2013-07-17

    Biomet Recalls Oxford Fixed Bearing Partial Knee Implants

    Biomet is recalling 23 Oxford Fixed Bearing Partial Knee implants due to a design flaw that may cause bone impingement.

    Product
    REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
    Category
    Medical Device
    Distribution
    4 states

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