Device product
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Z-0656-2017
Product summary
- Event
- Event 75580
- Status
- Terminated
- Classification
- Class II
- Quantity
- 198 units
- Official record key
device-enforcement:Z-0656-2017
Official wording
Reason: Non-conforming material used.
Code information: Part Number 352.040 - Lot # 9947895, L084498 Part Number 352.044 - Lot # 9916503 9916508,L000158,L000160,L000573,L000603,L000604,L000605,L000607,L000632 L082974
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Non-conforming material used.