FDA Device recall Z-0276-2016
Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following…
- FDA Device
- Class II
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class II recall of Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following… by Synthes Usa Products, citing 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 2….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0276-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-19 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | CA, CO, IL, KY, LA, MA, MI, NE, OH, OK, PA, TX, UT, WA, WI |
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.
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.
Identifiers
| code_info | Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0276-2016%22
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