Device product
EVOLVE STEM 8.5MM Model # 496S085
Z-2989-2020
Product summary
- Event
- Event 86278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 16 stems
- Official record key
device-enforcement:Z-2989-2020
Official wording
Reason: Lack of sterility assurance
Code information: Lot # 1668777
Distribution pattern: USA states: CA, CO, FL, GA, MA, MO, OH, PA, TX OUS: Australia, Canada, Chile, Israel, Spain
Derived failure modes
-
Sterility assurance
Lack of sterility