Device product
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Z-2637-2016
Product summary
- Event
- Event 74850
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-2637-2016
Official wording
Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Code information: P239168, P239169
Distribution pattern: AR, MN,MA
Derived failure modes
-
Unknown
The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.