Synthes Application Instrument for Sternal ZIPFIX — Class II medical device recall Z-2475-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-09-02, distributed nationwide. The end cap may loosen and detach making the instrument non-functional. No injuries reported.
| Recall number | Z-2475-2015 |
|---|---|
| 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 | 2015-07-22 |
| Classified | 2015-08-27 |
| Reported by FDA | 2015-09-02 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 451 |
| Reason classes | device malfunction |
| Lot numbers | 3783492, 3783913, 3788496, 3822332, 7516728, 7606881, 7635218, 7653178, 7659168, 7666085, 7671934, 7679825, 7689244, 7694377, 7700691, 7705157, 7720599, 7738572, 7738573, 7740498, 7742713, 7767497, 7797648, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 7858407, 8068078, 8130898, 8130975, 8145793, 8159386, 8166417, 8186954, 8207769 and 6 more |
| 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
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
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-2475-2015. 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.