Device product
2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
Z-0167-2016
Product summary
- Event
- Event 72345
- Status
- Terminated
- Classification
- Class II
- Quantity
- 98
- Official record key
device-enforcement:Z-0167-2016
Official wording
Reason: Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw.
Code information: Part Number 202.212 Lot Number 3420620
Distribution pattern: US Distribution to the state of : TN
Derived failure modes
-
Labeling or packaging
mislabeled