🔍 RecallPedia

TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)

Class I - Dangerous
🏥 Medical Devices Recalled: November 11, 2024 Gauthier Biomedical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
  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:
Gauthier Biomedical, Inc.
Reason for Recall:
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)

Product Codes/Lot Numbers:

Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0572-2025