Device product
Synapse System 3.5mm TI Cancellous Polyaxial Screws, Part No. 04.615.026 for use in spinal surgery
Z-0223-2020
Product summary
- Event
- Event 83948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6
- Official record key
device-enforcement:Z-0223-2020
Official wording
Reason: The subject product measures 4.0mm in diameter instead of 3.5mm.
Code information: 10L2702
Distribution pattern: Distributed to NJ.
Derived failure modes
-
Unknown
The subject product measures 4.0mm in diameter instead of 3.5mm.