TriALTIS TORQUE LIMITER — Class II medical device recall Z-0572-2025
Ongoing recall by Gauthier Biomedical, Inc., reported 2024-12-04, distributed nationwide. An out of specification component may result in the device exhibiting torque output higher than the design spe
| Recall number | Z-0572-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gauthier Biomedical, Inc., Grafton, WI, United States |
| Recall initiated | 2024-11-11 |
| Classified | 2024-11-27 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 160 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00858325005688 |
| Lot numbers | GB153869, GB156110 |
| Model numbers | 5161-00-5048 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0572-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.