Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
This recall is currently active, issued November 2, 2023. It was issued by Corin Ltd Unit 1-57-8 Corinium Centre Cirencester United Kingdom.
- Recall Initiated
- October 13, 2023
- Posted
- November 2, 2023
- Recall Number
- Z-0213-2024
- Quantity
- 3 units
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US: MI, TX, IL
Lot / Code Info
UDI/DI: (05055343872499, Lot Number: 529803.
Root Cause
Process change control
Action Taken
Corin issued a FIELD SAFETY NOTICE/RECALL LETTER to its consignees on 10/13/2023 via email. The notice explained the problem, potential risk if used, and requested the return of unused units. Distributors were directed to communicate the notice to applicable hospitals.