Device product
NEOVIEW(R) SCREWS SET, REF W27 ST900, STERILE R The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius
Z-0954-2017
Product summary
- Firm
- In2Bones, SAS
- Event
- Event 76104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0954-2017
Official wording
Reason: Dimensional non-conformity of the thread on the screw head.
Code information: Lot number 1602134
Distribution pattern: Worldwide Distribution - US TN only and Internationally to France and Switzerland
Derived failure modes
-
Unknown
Dimensional non-conformity of the thread on the screw head.