🔍 RecallPedia

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

Class I - Dangerous
🏥 Medical Devices Recalled: January 8, 2021 DePuy Orthopaedics Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
  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:
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

Product Codes/Lot Numbers:

Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1103-2021

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