FDA-Device2024-12-04Class II
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Gauthier Biomedical, Inc.
Hazard
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Sold states
US Nationwide distribution in the state of MA.
Affected count
160 units
Manufactured in
2221 Washington St, Grafton, WI, United States
Products
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0572-2025Don't want to check this manually?
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