Device product
APTUS 2.8 TriLock Screw 22mm, HD7, 1/Pkg. Metal bone fixation fastener used with the APTUS fixation system.
Z-1821-2024
Product summary
- Firm
- Medartis Inc.
- Event
- Event 94445
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-1821-2024
Official wording
Reason: Screw is 16mm long instead of 22mm long.
Code information: Part No. A-5850.22/1; UDI-DI: 76300378022PA; Lot No. 24377397.
Distribution pattern: Worldwide - US Nationwide distribution in the state of TX and the countries of Australia, Czech Republic, Finland, France, Germany, Poland, South Africa, & Switzerland.
Derived failure modes
-
Unknown
Screw is 16mm long instead of 22mm long.