Trialtis Torque Limiter recall
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Why was Trialtis Torque Limiter recalled?
An out of specification component may result in the device exhibiting torque output higher than the design specification.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
- Product
- TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- Recalling firm
- Gauthier Biomedical, Inc.
- Quantity
- 160 units
- Distribution
- US Nationwide distribution in the state of MA.
- Recall date
- December 4, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)