Device product
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
Z-0213-2024
Product summary
- Firm
- Corin Ltd
- Event
- Event 93144
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0213-2024
Official wording
Reason: Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.
Code information: UDI/DI: (05055343872499, Lot Number: 529803.
Distribution pattern: US: MI, TX, IL
Derived failure modes
-
Unknown
Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.