UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N
  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:
Howmedica Osteonics Corp.
Reason for Recall:
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042

Product Codes/Lot Numbers:

GTIN: 07613327032369 Lot Numbers: 4615EX, HE645D, 8A399N

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2371-2024

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