Synthes Application Instrument Sternal Zip Flex System intended for… — Class II medical device recall Z-0114-2014
Terminated recall by Synthes USA HQ, Inc., reported 2013-11-06, distributed nationwide. When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensi
| Recall number | Z-0114-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes USA HQ, Inc., West Chester, PA, United States |
| Recall initiated | 2013-08-13 |
| Classified | 2013-10-30 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 319 |
| 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 |
| Model numbers | 03.501.080 |
Product
Synthes Application Instrument Sternal Zip Flex System intended for use in 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
When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant.
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-0114-2014. 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.