TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
FDA Recall #Z-0572-2025 — Class II — November 11, 2024
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.
Recalling Firm
Gauthier Biomedical, Inc. — Grafton, WI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
160 units
Distribution
US Nationwide distribution in the state of MA.
Code Information
Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated