Device product
Reusable instruments in the Knee, Hip, Trauma, and Extremities segments.
Z-2198-2017
Product summary
- Event
- Event 77223
- Status
- Terminated
- Classification
- Class II
- Quantity
- Greater than 10,000,000 last 10 years
- Official record key
device-enforcement:Z-2198-2017
Official wording
Reason: Durability characteristics of reusable instruments were not established
Code information: All lots in distribution prior to 5/8/17
Distribution pattern: Nationwide Worldwide
Derived failure modes
-
Unknown
Durability characteristics of reusable instruments were not established