Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Recall Initiated
- October 13, 2023
- Posted
- November 2, 2023
- Recall Number
- Z-0214-2024
- Quantity
- 1 units
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 05055343872505, Lot Number 532405.
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.