Recall Z-0572-2025— Gauthier Biomedical, Inc.
Class II · Ongoing
Class II FDA medical device recall by Gauthier Biomedical, Inc., initiated 2024-11-11. FDA's recall record names no specific 510(k) clearance for this event. Product: TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509). Reason: An out of specification component may result in the device exhibiting torque output higher than the design specification..
- Recalling firm
- Gauthier Biomedical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-11-11
- Firm location
- Grafton, WI, United States
Product description
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Reason for recall
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.