Device product
Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
Z-0681-2017
Product summary
- Event
- Event 75694
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84 units
- Official record key
device-enforcement:Z-0681-2017
Official wording
Reason: Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.
Code information: Model/Catalog # 316.15 Lot/Serial Number U172728
Distribution pattern: Distributed Nationwide
Derived failure modes
-
Labeling or packaging
incorrectly labeled