Device product
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)
Z-0572-2025
Product summary
- Event
- Event 95746
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 160 units
- Official record key
device-enforcement:Z-0572-2025
Official wording
Reason: An out of specification component may result in the device exhibiting torque output higher than the design specification.
Code information: Model No 5161-00-5048; UDI-DI 00858325005688; Lot Numbers: GB153869 and GB156110
Distribution pattern: US Nationwide distribution in the state of MA.
Derived failure modes
-
Potency or specification failure
out of specification