Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Part Number Range:00-8770-040-01/05 & 01.01062.405/408
  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, Inc.
Reason for Recall:
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.

Product Codes/Lot Numbers:

Part Number Range:00-8770-040-01/05 & 01.01062.405/408

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0071-2014

Related Recalls

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Dec 2, 2025 Other Medical Devices Nationwide View Details →

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Dec 2, 2025 Other Medical Devices Nationwide View Details →

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

Dec 2, 2025 Other Medical Devices Nationwide View Details →