Recall Z-0276-2016
Synthes (USA) Products LLC · initiated October 19, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659168, 7666085, 7671934, 7689244, 7694377, 7720599, 7738572, 7738573, 7740498, 7767497, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 8068078, 8130898, 8145793, 8207769, and 8215969.
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.
FDA-determined cause: Device Design
Action taken
Communication to the accounts having record of receiving this product was sent on October 19, 2015.
Details
- Recall number
- Z-0276-2016
- Initiated
- October 19, 2015
- Posted by FDA
- November 14, 2015
- Terminated
- August 26, 2016
- Product code
- JDQ – Cerclage, Fixation
- Quantity
- 267
- Distribution
- Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
- Recalling firm
- Synthes (USA) Products LLC, West Chester, PA