Device product
Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
Z-0702-2019
Product summary
- Event
- Event 81756
- Status
- Terminated
- Classification
- Class II
- Quantity
- 182 packs
- Official record key
device-enforcement:Z-0702-2019
Official wording
Reason: The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
Code information: Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948
Distribution pattern: US state of Florida
Derived failure modes
-
Unknown
The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.