Z-0572-2025 Class II Ongoing
FDA device recall Z-0572-2025 was initiated by Gauthier Biomedical, Inc. on November 11, 2024 and is designated Class II. Reason for recall: An out of specification component may result in the device exhibiting torque output higher than the design specification. The recall status is ongoing. Affected quantity: 160 units.
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