Device product
MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Z-1657-2025
Product summary
- Event
- Event 96615
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1657-2025
Official wording
Reason: Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
Code information: Version/Model: MC2-5090S; UDI-DI (with lot nuber): (01)00887517834041(11)250311(17)300311(10)GB1607ET
Distribution pattern: US Nationwide distribution in the state of AR.
Derived failure modes
-
Unknown
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.