Z-2051-2015 Class II Terminated
FDA device recall Z-2051-2015 was initiated by Synthes, Inc. on June 3, 2015 and is designated Class II. Reason for recall: A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection. The recall status is terminated (terminated September 15, 2015). Affected quantity: 3.
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2015
- Initiation Date
- June 3, 2015
- Termination Date
- September 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3
Product Description
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.
Reason for Recall
A specific part and lot number was packaged and shipped prior to the completion of a required internal inspection.
Distribution Pattern
US Distribution to states of: MO and SC.
Code Information
Part # 04.004.000, lot # 7950994