[Recalled] TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) — An out of specification component may result in the device exhibiting torque ou… | FDA 2024-11-11
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) |
|---|---|
| Brand / manufacturer | Gauthier Biomedical, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0572-2025 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 11 November 2024 |
| EAN / barcode | 00858325005688 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: An out of specification component may result in the device exhibiting torque output higher than the design specification.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.