Z-0572-2025 Class II Ongoing

Recalled by Gauthier Biomedical, Inc. — Grafton, WI

Recall Details

Product Type
Devices
Report Date
December 4, 2024
Initiation Date
November 11, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
160 units

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.

Distribution Pattern

US Nationwide distribution in the state of MA.

Code Information

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