Grafton, WI, United States
Gauthier Biomedical, Inc. recalls
1 recall recorded since 2018, most recently on 11 November 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 11 November 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0572-2025
- TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.