TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Reported: December 4, 2024 Initiated: November 11, 2024 #Z-0572-2025
Product Description
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.
Details
- Recalling Firm
- Gauthier Biomedical, Inc.
- Units Affected
- 160 units
- Distribution
- US Nationwide distribution in the state of MA.
- Location
- Grafton, WI
Frequently Asked Questions
What product was recalled? ▼
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509). Recalled by Gauthier Biomedical, Inc.. Units affected: 160 units.
Why was this product recalled? ▼
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2024. Severity: Moderate. Recall number: Z-0572-2025.
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