Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090
  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, Inc.
Reason for Recall:
Potential presence of elevated endotoxin levels that exceed the specification limit
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Knee Products: 141356 Regenerex Series-A Patella 3 Peg, 31 MM 141358 Regenerex Series-A Patella 3 Peg, 37 MM Product Usage: Knee prosthesis

Product Codes/Lot Numbers:

Lot Numbers: UDI Number 1) 561760 (01)00880304554412(17)211229(10)561760; 2) 091090 (01)00880304506084(17)211214(10)091090

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2146-2020

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