Reported Dec 4, 2024 · Ongoing
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Gauthier Biomedical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gauthier Biomedical, Inc. · 2221 Washington St · Grafton, WI · 53024-9506
Is this the product you have?
- TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- Lot codes and dates
Model No 5161-00-5048UDI-DI 00858325005688
- Lot NumbersGB153869 and GB156110
- Amount recalled
- 160 units
Where it was sold
- Nationwide
- MA
Why it was recalled
An out of specification component may result in the device exhibiting torque output higher than the design specification.
This product could cause temporary or reversible health problems — stop using it.
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