Class II
Medical Device Recall: TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Gauthier Biomedical, Inc. · November 11, 2024
Reason for Recall
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Distribution
US Nationwide distribution in the state of MA.
States Affected
NATIONWIDE
Quantity Affected
160 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0572-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.