🔍 RecallPedia

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

Class I - Dangerous
🏥 Medical Devices Recalled: February 22, 2021 DePuy Orthopaedics Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795
  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:
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

Product Codes/Lot Numbers:

Lot#: 9543538, Product Code: 129433130, GTIN 10603295025788 Lot#: 9553989, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554547, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554548, Product Code: 129433130, GTIN 10603295025788 Lot#: 9554551, Product Code: 129433130, GTIN 10603295025788 Lot#: 9548774, Product Code: 129433140, GTIN 10603295025795 Lot#: 9548777, Product Code: 129433140, GTIN 10603295025795 Lot#: 9554569, Product Code: 129433140, GTIN 10603295025795

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1315-2021

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