Device product
Unity Total Knee System. Used for knee prosthesis in total knee replacement
Z-0273-2023
Product summary
- Firm
- Corin Ltd
- Event
- Event 91039
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 devices
- Official record key
device-enforcement:Z-0273-2023
Official wording
Reason: The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.
Code information: Model Number: 112.040.06; Lot Number: 504337
Distribution pattern: Distribution in the US to New Jersy and Puerto Rico. International distribution to South Africa and France.
Derived failure modes
-
Unknown
The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging.