FDA Medical devices recall ·
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048… recall
- Recall number
- Z-0572-2025
- Date
- (initiated November 11, 2024)
- Company / brand
- Gauthier Biomedical, Inc.
2221 Washington St, Grafton, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Why was it recalled?
An out of specification component may result in the device exhibiting torque output higher than the design specification.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Distribution
US Nationwide distribution in the state of MA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0572-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.