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.
FDA Recall Z-0276-2016 · Posted 2015-11-14
Advertisement
Recalling FirmSynthes (USA) Products LLC
Recall StatusTerminated
Product CodeJDQ
Date Initiated2015-10-19
Date Terminated2016-08-26
Product Quantity267
Reason for Recall
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.
Firm Action
Communication to the accounts having record of receiving this product was sent on October 19, 2015.
Root Cause
Device Design
Distribution Pattern
Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement