FDA Enforcement
Class II
Ongoing
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Recall: Z-0572-2025
·
Reported December 4, 2024
Enforcement
- Recall Number
- Z-0572-2025
- Event ID
- 95746
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Gauthier Biomedical, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 4, 2024
- Initiation Date
- November 11, 2024
- Classification Date
- November 27, 2024
- Address
- 2221 Washington St, Grafton, WI, 53024-9506, United States
Description
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.
Code Info
Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Distribution
US Nationwide distribution in the state of MA.
Quantity
160 units