Gauthier Biomedical, Inc. recalls TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- Recall date
- November 11, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0572-2025
- FDA classification
- Class II
- Brand / firm
- Gauthier Biomedical, Inc.
- Sold / distributed
- US Nationwide distribution in the state of MA.
Why it was recalled
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
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