FDAFDA · Food and drugs·Recall number Z-0572-2025
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Published December 4, 2024 · Recall initiated: November 11, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
An out of specification component may result in the device exhibiting torque output higher than the design specification.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gauthier Biomedical, Inc.
- Distributor
- US Nationwide distribution in the state of MA.
- Lot
- Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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