FDA recall Z-0572-2025

Gauthier Biomedical, Inc. · Class II · device

Product

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

US Nationwide distribution in the state of MA.

Key facts

Status
Ongoing
Initiation date
2024-11-11
Report date
2024-12-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Grafton, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0572-2025