🔍 RecallPedia

Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.

Class I - Dangerous
🏥 Medical Devices Recalled: November 7, 2014 DePuy Orthopaedics Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684
  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:
DePuy Orthopaedics, Inc.
Reason for Recall:
Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.

Product Codes/Lot Numbers:

Lot 7928614 CATALOG NO. : 1365-36-740 Barcode GTIN: 10603295033684

Distribution:

Distributed in: WV, AZ, AL

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0825-2015

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