Device product
NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France 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-0953-2017
Product summary
- Firm
- In2Bones, SAS
- Event
- Event 76104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 units
- Official record key
device-enforcement:Z-0953-2017
Official wording
Reason: Dimensional non-conformity of the thread on the screw head.
Code information: Lot Numbers: 1604154, 1605083, 1606068
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.