🔍 RecallPedia

Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

Class I - Dangerous
🏥 Medical Devices Recalled: October 17, 2014 Biomet Microfixation Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    Models 24-6646TI, Lot #s: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, 538720D
  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:
Biomet Microfixation, LLC
Reason for Recall:
Laser etching on the parts is wider and deeper than the conditions previously validated.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint

Product Codes/Lot Numbers:

Models 24-6646TI, Lot #s: 526000A, 526000B, 526010B, 526010A, 535390A, 535390B, 535390C, 535390D, 538720A, 538720B, 538720C, 538720D

Distribution:

Distributed in: PA, MN, CA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0510-2015

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