TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752
  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:
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 702-11-54E

Product Codes/Lot Numbers:

UDI-DI:(01)07613327380880(17)290313(10) Lot Number: 15293151 15293153 15293152 15432252 15432254 15432451 15432351 15432251 15432253 16265752

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1625-2024

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