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Gauthier Biomedical, Inc. recalls TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Recalled December 4, 2024 · FDA recall Z-0572-2025 · Gauthier Biomedical
Hazard
An out of specification component may result in the device exhibiting torque output higher than the design specification. · FDA Class II
Units
160 units
Sold at
US Nationwide distribution in the state of MA.
Description
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Product
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Manufacturer(s)
Gauthier Biomedical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →