The Recall Desk

Manufacturer

Stryker Howmedica Osteonics Corp.

87 recalls in our database name Stryker Howmedica Osteonics Corp. as the manufacturing or recalling firm.

What the numbers show

Total
87
Critical
0
Severe
8
Most recent
2017-05-31

Of the 87 recalls from Stryker Howmedica Osteonics Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

51–75 of 87

  • ModerateFDA (Devices)·Z-1241-2015·2015-03-11

    Stryker Recalls V40 Femoral Heads Due to Assembly Issues

    Stryker Howmedica Osteonics is recalling nine V40 femoral heads because they could not be assembled with their corresponding stem trunnions.

    Product
    LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1043-2015·2015-02-11

    Stryker Recalls Trident PSL Hip Shells Missing Dome Hole Plugs

    Stryker Howmedica Osteonics is recalling seven units of Trident PSL HA Solid Back 50 mm hip shells because the dome hole plugs were missing from the packages.

    Product
    Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0065-2015·2014-10-22

    Stryker T2 Tibia Nail Insertion Sleeve Recall Due to Diameter Mismatch

    Stryker is recalling T2 Tibia Nail Insertion Sleeves because some units have a different inner diameter than labeled.

    Product
    Stryker T2 Tibia System Nail Insertion Sleeve, Elastic, Sterile, a) REF 1806-1406S, SPI 08-11 and b) REF 1806-1407S, SPI 08-13. Product Usage: The T2 Tibial Nailing system is intended to provide temporary stabilization of various types of fractures, malunion and nonunion of t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1978-2014·2014-07-09

    Stryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk

    Stryker Howmedica Osteonics is recalling 22 units of the Triathlon Tritanium Patella Inserter because the instrument may fracture during implantation.

    Product
    Stryker Orthopaedics Triathlon Tritanium Patella Inserter, . NON-STERILE Product Usage: The Triathlon Tritanium Patella Inserter is part of the Tritanium Knee System Instrument Set. It is used to implant the Tritanium Patella after the patellar bone has been prepared using th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1317-2014·2014-04-09

    Stryker Recalls Specific Hip Stems Due to Packaging Error

    Stryker Howmedica Osteonics is recalling 48 Citation V40 Hip Stems because a left-sided implant was found in packaging labeled for a right-sided implant.

    Product
    Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0964-2014·2014-02-19

    Stryker Accolade Broach Handle Recalled Due to Impaction Plate Fracture

    Stryker Howmedica Osteonics Corp. is recalling 211 units of the Navigation Compatible Accolade Broach Handle because the impaction plate may dissociate or fracture from the main body.

    Product
    Stryker Orthopaedics Navigation Compatible Accolade Broach Handle 1 single unit to a package Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 Meyzieu Cedex France Made in USA non-sterile
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0975-2014·2014-02-19

    Stryker Recalls Incorrect Patient-Specific Customized Implant Kit

    Stryker Howmedica Osteonics is recalling a patient-specific CMF Customized Implant Kit because an incorrect unit was delivered to a hospital in Pennsylvania.

    Product
    Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) 5444-01-102 Host Bone; Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA. Designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or cr
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0849-2014·2014-02-05

    Stryker Recalls Sterile Teflon Tubes Due to Potential Seal Compromise

    Stryker is recalling 34 units of sterile Teflon tubes used in orthopedic nailing systems because laboratory testing indicated the sterile barrier seal may be compromised.

    Product
    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0583-2014·2014-01-01

    Stryker Orthopaedics Ball Impactor Tip Recalled for Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling Ball Impactor Tips used in surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Ball Impactor Tip Product Usage: Used for ADM Surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0582-2014·2014-01-01

    Stryker Orthopaedics Recalls Rim Impactor Tips Due to Cracks and Fractures

    Stryker Howmedica Osteonics Corp. is recalling 1,690 Rim Impactor Tips used in MDM surgery due to complaints of cracks and fractures.

    Product
    Stryker Orthopaedics Rim Impactor Tip Product Usage: Used for MDM surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0467-2014·2013-12-18

    Stryker Recalls Accolade II Hip Stems Due to Packaging Error

    Stryker is recalling 20 Accolade II Hip Stems because a Size #3 was found packaged with a Size #5. The error poses a risk of incorrect implant selection.

    Product
    1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5 Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA Telephone # +1 201-831-5000 Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0483-2014·2013-12-18

    Stryker Recalls Cancellous Bone Screws Due to Packaging Error

    Stryker is recalling specific Cancellous Bone Screws because a 5.5 mm screw was found in packaging labeled for a 6.5 mm screw.

    Product
    Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in To
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2130-2013·2013-09-04

    Stryker Triathlon Tibial Alignment Ankle Clamp Recalled for Cracks

    Stryker is recalling 10,537 Triathlon Tibial Alignment Ankle Clamps due to cracks or fractures. The instruments are used in total knee arthroplasty.

    Product
    Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. N
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2099-2013·2013-09-04

    Stryker Recalls Asnis III Cannulated Screws Due to Incorrect Length

    Stryker is recalling 23 units of Asnis III Cannulated Screws because the length of the device was reported to be incorrect.

    Product
    Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) Asnis III Cannulated Screw REF 604642S 4.0x42mm TL 14mm, sterile Product Usage: The Asnis III Cannulated Screw System is intended for fracture fixation of small and long bones and of the pelvis. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2013·2013-08-07

    Stryker Recalls Left GAMMA3 Nails Marked as Right

    Stryker Howmedica Osteonics is recalling five units of the GAMMA3 System Long Nail Kit, Left, because they are incorrectly marked as right nails.

    Product
    GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1370-2013·2013-05-29

    Stryker Triathlon Femoral Distal Augment Recalled for Packaging Label Errors

    Stryker Howmedica Osteonics is recalling 11 units of Triathlon Femoral Distal Augments due to external packaging label errors, including an incorrect glyph and missing size reference.

    Product
    Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA Stryker France, ZAC Satolas Green Pusignan, Av de Satoles Green 69881 Meyzieu, Cedex, France This device is used w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2013·2013-05-08

    Stryker AxSOS Drill Bit Recalled Due to Incorrect Scale

    Stryker Orthopaedics is recalling AxSOS Calibrated Drill Bits because an incorrect scale may cause surgeons to select screws that are 10mm longer than intended.

    Product
    Stryker Howmedica Osteonics Corp. AxSOS System Instrument. The AxSOS Locking Plate System is designed to treat periarticular or intraarticular fractures of the Distal Femur, Proximal Humerus, Proximal Tibia, and the Distal Tibia. Per the operative technique, " A 4.3 mm Drill
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1052-2013·2013-04-24

    Stryker Recalls ShapeMatch Cutting Guides Due to Internal Process Issues

    Stryker Orthopaedics is recalling ShapeMatch Cutting Guides used in knee surgeries due to potential issues with internal planning and production processes.

    Product
    ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1061-2013·2013-04-17

    Stryker Recalls Baseplate Impactor Extractor Instruments Due to Handle Detachment

    Stryker Howmedica Osteonics is recalling 871 Baseplate Impactor Extractor instruments because the handle may detach from the cam during surgery.

    Product
    Stryker Orthopaedics Baseplate Impactor Extractor TRIATHLON Instruments. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430 USA A subsidiary of Stryker Corporation. Made in USA. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881 MEYZIEU Cedex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0964-2013·2013-03-27

    Stryker Specialty Triathlon Knee Sizer Adjustment Housing Recalled for Fit and Marking Errors

    Stryker is recalling four units of Specialty Triathlon Knee Sizer Adjustment Housings because the standard femoral stylus does not fit and the left/right markings on the right sizer are reversed.

    Product
    Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and Right A//P Sizer Adjustment Housing PER File K2401. For use in knee prosthesis implantation. NON-STERILE
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0919-2013·2013-03-20

    Stryker Howmedica Command Instrument Broach Handle Recalled for Fracture Risk

    Stryker Howmedica is recalling 48 Command Instrument Broach Handles used in hip surgery due to reports of handle fracture and component disassociation.

    Product
    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0695-2013·2013-01-23

    Stryker Recalls Hoffman LRF Wire Bolts Due to Breakage During Use

    Stryker Howmedica Osteonics is recalling 476 Hoffman LRF Wire Bolts because two complaints reported the wires broke during load-bearing application by patients.

    Product
    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0656-2013·2013-01-16

    Stryker Recalls Accolade Hip Stems Due to Packaging Mix-Up

    Stryker is recalling specific Accolade hip stems because size 3.5 stems were mistakenly packaged as size 2.5 stems, creating a risk of product mix-up.

    Product
    Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #2.5 and Accolade TMZF Plus 127 degree Neck Angle V40 Hip Stem #3.5, Howmedica Osteonics Corp. The intended use is for reconstruction of the head and neck of the femoral joint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2013·2013-01-02

    Stryker T2 Humerus System Teflon Tube Recalled Due to Material Embrittlement

    Stryker Howmedica Osteonics is recalling 100 units of the T2 Humerus System Teflon Tube because a manufacturing error caused the tube material to become embrittled.

    Product
    Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0469-2013·2012-12-12

    Stryker Orthopaedics Recalls Mismarked Femoral Offset Bushing Instruments

    Stryker Howmedica Osteonics Corp. is recalling 7 units of non-sterile Femoral Offset Bushing Triathlon Revision Instruments due to incorrect or missing rotational markings.

    Product
    Stryker Orthopaedics FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69881
    Category
    Medical Device
    Distribution
    0 states