🔍 RecallPedia

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Class I - Dangerous
🏥 Medical Devices Recalled: July 1, 2021 DePuy Orthopaedics Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
  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:
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080

Product Codes/Lot Numbers:

Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2348-2021

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