Synthes Application Instrument for Sternal ZIPFIX — Class II medical device recall Z-0276-2016
Terminated recall by Synthes (USA) Products LLC, reported 2015-11-25, distributed in CA, CO, IL, KY, LA, MA, MI, NE…. Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015
| Recall number | Z-0276-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-10-19 |
| Classified | 2015-11-13 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-08-26 |
| Distributed | CA, CO, IL, KY, LA, MA, MI, NE, OH, OK, PA, TX, UT, WA, WI |
| Quantity | 267 |
| Reason classes | device malfunction |
| 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, 8215969 |
| Model numbers | 03.501.080 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0276-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.