Recall Z-0276-2016 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 | Nov 14, 2015 (initiated Oct 19, 2015) |
| Status | Terminated |
| Reason | Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device. |
| Root cause | Device Design |
| Action | Communication to the accounts having record of receiving this product was sent on October 19, 2015. |
| Quantity | 267 |
| Distribution | Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110789 | SYNTHES STERNAL ZIPFIX SYSTEM Synthes (Usa), Jul 28, 2011 |