various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150
  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:
Zimmer Biomet, Inc.
Reason for Recall:
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

various polyethylene implants Sports Med Repicci II Tibial Components Product Usage: Partial knee replacement

Product Codes/Lot Numbers:

Items and lots: Item 102140 372580 Item 102152 361720 Item 102160 347140 Item 102168 129360 Item 102176 129370 Item 102178 866150

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1863-2017

Related Recalls

Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.

Nov 17, 2020 Other Medical Devices Nationwide View Details →