Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
FDA device recall Z-0214-2024 · posted 2023-11-02 · Open, Classified
Recall details
- Recalling firm
- Corin Ltd
- 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.
- 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.
- Root cause
- Process change control
- Status
- Open, Classified
- Product code
- JWH
- Quantity affected
- 1 units
- Distribution
- US: MI, TX, IL
- Date initiated
- 2023-10-13
- Date posted
- 2023-11-02
- Location
- Cirencester, United Kingdom
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNITY TOATAL KNEE SYSTEM (K113060) | Corin USA | 2012-09-10 |