Device product
TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fractures; and tibial malunions and non-unions.
Z-2051-2015
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 71440
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3
- Official record key
device-enforcement:Z-2051-2015
Official wording
Reason: A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Code information: Part # 04.004.000, lot # 7950994
Distribution pattern: US Distribution to states of: MO and SC.
Derived failure modes
-
Unknown
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.