The Recall Desk

FDA (Devices) recall action 76507

Zimmer Biomet, Inc. recalled 6 products on 2017-04-26

The FDA (Devices) publishes a recall like this one as 6 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 6 pages.

Products
6
Announced
2017-04-26
Critical
0
Units
169,518

Why these products were recalled

Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–6 of 6

  • HighFDA (Devices)··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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states
  • HighFDA (Devices)··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
    Distribution
    0 states