🔍 RecallPedia

Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

Class I - Dangerous
🏥 Medical Devices Recalled: February 15, 2023 DePuy Orthopaedics Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    GTIN: 10603295049944; Lot: JN6613
  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 subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507

Product Codes/Lot Numbers:

GTIN: 10603295049944; Lot: JN6613

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1267-2023

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