Recall Z-2475-2015 ยท JDQ Cerclage, Fixation
Synthes (USA) Products LLC
Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
| Date | Aug 27, 2015 (initiated Jul 22, 2015) |
| Status | Terminated |
| Reason | The end cap may loosen and detach making the instrument non-functional. No injuries reported. |
| Root cause | Device Design |
| Action | Urgent recall notification letters, dated July 22, 2015 were sent to end users and consultants to inform them of the issue, the associated risks, and provided instructions to return affected devices along with the response form. |
| Quantity | 451 |
| Distribution | Nationwide and internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM Synthes (Usa), Jul 28, 2011 |