Gauthier Biomedical, Inc.: Device Recall
Recall #Z-0572-2025 · 11/11/2024
Class II: Risk
Recall Details
- Recall Number
- Z-0572-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Gauthier Biomedical, Inc.
- Status
- Ongoing
- Date Initiated
- 11/11/2024
- Location
- Grafton, WI, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160 units
Reason for Recall
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Product Description
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Distribution Pattern
US Nationwide distribution in the state of MA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.