🔍 RecallPedia

Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Class I - Dangerous
🏥 Medical Devices Recalled: January 5, 2016 Biomet U.K. Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Item:32-420663, Lots: ZB160601, ZB160701
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Biomet U.K., Ltd.
Reason for Recall:
Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Product Codes/Lot Numbers:

Item:32-420663, Lots: ZB160601, ZB160701

Distribution:

Distributed in: LA, NC, AR, MT, MO, CA, NY, KS, TX, MA, KY, OK, SC, NJ

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1170-2017

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