FDA Device recall Z-0572-2025
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
- FDA Device
- Class II
- ongoing
- Published 2024-12-04
On 2024-12-04 the FDA classified a Class II recall of TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509) by Gauthier Biomedical, citing an out of specification component may result in the device exhibiting torque output higher than the design specification.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0572-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-11 |
| Published | 2024-12-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Gauthier Biomedical |
| Distribution | US |
Product
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Reason
An out of specification component may result in the device exhibiting torque output higher than the design specification.
Identifiers
| code_info | Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0572-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.