The Recall Desk

Manufacturer

Zimmer Biomet, Inc.

875 recalls in our database name Zimmer Biomet, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
875
Critical
0
Severe
129
Most recent
2020-12-30

Of the 875 recalls from Zimmer Biomet, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 129 (15%) 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.

826–850 of 875

  • HighFDA (Devices)·Z-1862-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling 28,253 custom polyethylene implants because endotoxin levels exceeded process maximum limits. The affected parts were distributed worldwide.

    Product
    various polyethylene implants Custom parts Product Usage: Custom
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1863-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling Repicci II Tibial Components for partial knee replacement because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1859-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling 28,253 polyethylene implants for shoulder and elbow replacements because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants Extremities, Shoulders and Elbows BioModular Shoulder System; Comprehensive Shoulder System; Comprehensive Reverse Shoulder System Product Usage: Shoulder Replacement Elbow Replacement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1858-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Implants Due to High Endotoxin Levels

    Zimmer Biomet is recalling BIO PLUG 10MM polyethylene implants because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants BIO PLUG 10MM Product Usage: Non-weight bearing accessory. Sterile, optional speciality components that are non-bioabsorbable, implantable devices designed to be inserted into the medullary canal of a bone during orhtopedic surgery to preve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1860-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Hip Implants Due to Endotoxin Levels

    Zimmer Biomet is recalling 28,253 polyethylene hip implant components worldwide because endotoxin levels exceeded process maximum limits.

    Product
    various polyethylene implants Hips Active Articulation ArComXL Bearings Active Articulation E1 Bearings Arcos Taper Cap BIOLOX delta Option Head E1 RingLoc Bi-Polar Freedom Constrained Liner +5mm Hi-Wall ArcomXL All Poly Rimloc E1 10 Degree Liner RingLoc +3mm Hi-Wall
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2017·2017-04-26

    Zimmer Biomet Recalls Polyethylene Knee Implants Due to Endotoxin Levels

    Zimmer Biomet is recalling 28,253 polyethylene knee implants because endotoxin levels exceeded process maximum limits. The affected products were distributed worldwide.

    Product
    various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Va
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1755-2017·2017-04-19

    Zimmer Biomet Recalls MEDTECH ROSA Spine Software Due to Unapproved Change

    Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.

    Product
    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2017·2017-04-19

    Zimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.

    Product
    MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1495-2017·2017-03-29

    Zimmer Biomet Recalls Orthosize Templating Software Due to Incorrect Files

    Zimmer Biomet is recalling Orthosize Templating Version 1.2.6 digital templates because they were created with incorrect files, affecting preoperative planning for orthopedic surgery.

    Product
    Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1103-2017·2017-02-22

    Zimmer Biomet Recalls Reverse Shoulder Humeral Trays Due to Fracture Risk

    Zimmer Biomet is recalling 4,388 Comprehensive Reverse Shoulder System Humeral Trays because they are fracturing at higher-than-anticipated rates, posing a risk of revision surgery.

    Product
    Comprehensive Reverse Shoulder System Humeral Tray Model 115340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2017·2017-02-22

    Zimmer Biomet Recalls Vanguard Total Knee Plates Due to Material Inclusions

    Zimmer Biomet is recalling Vanguard Total Knee punch-through trial plates due to potential alumina inclusions in the raw material that could cause the instruments to crack or separate.

    Product
    Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1115-2017·2017-02-08

    Zimmer Biomet Recalls Vanguard Total Knee System Femoral Components Due to Labeling Errors

    Zimmer Biomet is recalling Vanguard Total Knee System femoral components because packaging labels may incorrectly identify the size or side of the implant.

    Product
    Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2017·2017-02-08

    Zimmer Biomet Recalls Mislabelled Orthopedic Salvage System Tibial Bodies

    Zimmer Biomet is recalling 16 Orthopedic Salvage System tibial bodies because labels incorrectly identify them as AVL Modular Proximal Tibia components.

    Product
    Orthopedic Salvage System (OSS) 9cm prosthesis, knee, femorotibial, constrained, cemented, metal/polymer Knee System Tibial Bodies
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1024-2017·2017-01-25

    Zimmer Biomet Recalls ArComXL Polyethylene Liners Due to Labeling Mismatch

    Zimmer Biomet is recalling 36 units of ArComXL polyethylene liners because packaging labels did not match the physical product, posing a risk of surgical delay.

    Product
    RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1025-2017·2017-01-25

    Zimmer Biomet Recalls ArComXL Polyethylene Bearings Due to Labeling Mismatch

    Zimmer Biomet is recalling 19 ArComXL Polyethylene Bearings because packaging labels did not match the physical product inside, posing a risk of surgical delay.

    Product
    Active Articulation ArComXL Polyethylene Bearings Active Articulation ArComXL Bearings item XL-200152
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0956-2017·2017-01-18

    Zimmer Biomet Recalls Oxford Fixed Lateral Bearings Due to Mislabeling

    Zimmer Biomet is removing a specific lot of Oxford Fixed Lateral Bearings because packages labeled as 'Right' contained 'Left' bearings.

    Product
    Oxford Fixed Lateral Bearing Size F Right, Part Number 154375 Lot 744260, Sterile, The product is placed into an Aluminum Oxide coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed part is then placed into a coated 1073B Tyvek/film pouch and heat sealed. This
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0317-2017·2016-11-02

    Zimmer Biomet Recalls Patellofemoral Joint Prosthesis Milling Handpieces

    Zimmer Biomet is recalling 703 Patellofemoral Joint Prosthesis Milling Handpieces because they may be inoperable due to lack of preventative maintenance, potentially delaying surgery.

    Product
    Zimmer¿ Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2017·2016-10-26

    Zimmer Biomet Recalls Uniflex Humeral Nail Guide Pins Due to Packaging Error

    Zimmer Biomet is recalling 22 units of Uniflex Humeral Nail guide pins because they may be packaged with the wrong combination of pins, potentially causing surgical delays or injury.

    Product
    Uniflex Humeral Nail: 467265 G-PIN 2.8BL 3.2PL 60CM 2PK Pin, Fixation, Smooth A 467265-01 Ball Tip Guide Pin is used to guide reamers down the humeral canal during a Uniflex Humeral Nail procedure. A 467255-02 Plain Guide Pin is used to guide a Uniflex Humeral Nail implant in
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0111-2017·2016-10-26

    Zimmer Biomet Recalls Vanguard Distal Femoral Augments Due to Labeling Error

    Zimmer Biomet is recalling five Vanguard Distal Femoral Augments because the product inside the carton does not match the label. The mismatched size is easily identified during surgery.

    Product
    Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:  Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0084-2017·2016-10-19

    Zimmer Biomet Recalls Phoenix Recon Targeting Arm Surgical Instruments

    Zimmer Biomet is recalling 31 Phoenix Recon Targeting Arm surgical instruments because old and new revisions are not interchangeable, potentially causing surgical delays.

    Product
    Phoenix Recon Targeting Arm Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by tra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0083-2017·2016-10-19

    Zimmer Biomet Recalls Phoenix Recon Soft Tissue Sleeve Guide Instruments

    Zimmer Biomet is recalling 31 Phoenix Recon Soft Tissue Sleeve Guides due to incompatibility with new revision targeting arms, which may cause surgical delays.

    Product
    Phoenix Recon Soft Tissue Sleeve Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm Product Usage: The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2017·2016-10-12

    Zimmer Biomet Recalls Vanguard 360 Knee Prostheses Due to Bolt Defect

    Zimmer Biomet is recalling 454 Vanguard 360 Revision Knee System prostheses because a manufacturing defect in the tibial augment bolts may prevent them from being fully tightened during surgery.

    Product
    Vanguard 360 Revision Knee System Knee prostheses
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-2752-2016·2016-09-14

    Zimmer Biomet Recalls Coonrad/Morrey Elbow Replacement Kits Due to Missing Parts

    Zimmer Biomet is recalling a specific lot of Coonrad/Morrey Elbow Pin/Bushing Replacement Kits because they are missing a humeral bushing, which could delay surgery.

    Product
    Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small. This product is sold sterile. The parts are placed into an inner cavity and are sealed using a nitrogen process. The inner cavity is then placed into an outer cavity and heat sealed with outer Tyvek lid on the o
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1917-2016·2016-06-15

    Zimmer Biomet Recalls Persona Trabecular Metal Tibial Plate Instruments

    Zimmer Biomet is recalling specific Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets due to incidents of radiolucent lines and loosening in implants.

    Product
    Persona Trabecular Metal Tibia; Persona Trabecular Metal Tibial Plate Instruments and Modular Brackets; Used to facilitate the implantation of joint replacement implants.
    Category
    Medical Device
    Distribution
    30 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Zimmer Biomet Holdings

medical device company

Country
United States
Founded
1927

Official website

Source: Wikidata (Q203552), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.