Device product
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Z-0603-2018
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 78064
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 devices
- Official record key
device-enforcement:Z-0603-2018
Official wording
Reason: Vix Bit may fracture during use.
Code information: Catalog No. 531-15-08, Lot No. 75296003, 80129003, 81327001
Distribution pattern: Worldwide Distribution: US states of Florida and California, Australia, France, Spain, and United Kingdom.
Derived failure modes
-
Unknown
Vix Bit may fracture during use.