Recall Z-1410-2017 ยท JDR Staple, Fixation, Bone
Integra LifeSciences Corp.
The UNI-CP System; Model Number: 330230SND.
| Date | Jan 25, 2017 |
| Status | Terminated |
| Reason | The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect. |
| Root cause | Device Design |
| Action | Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017. |
| Quantity | 39 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011716 | THE UNI-CLIP STAPLE New Deal, S.A., Aug 30, 2001 |