Recall Z-0214-2024 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Corin Ltd
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
| Date | Nov 2, 2023 (initiated Oct 13, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 1 units |
| Distribution | US: MI, TX, IL |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113060 | UNITY TOATAL KNEE SYSTEM Corin USA, Sep 10, 2012 |