🔍 RecallPedia

Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064

Class I - Dangerous
🏥 Medical Devices Recalled: August 8, 2024 Zimmer GmbH Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
  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 GmbH
Reason for Recall:
Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064

Product Codes/Lot Numbers:

UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-3133-2024

Related Recalls

Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1066

Zimmer GmbH

Class I - Dangerous

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

Aug 8, 2024 Implants & Prosthetics Nationwide View Details →