FDA Device recall Z-0114-2014
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following ste…
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following ste… by Synthes Usa Hq, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0114-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-13 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Hq |
| Distribution | US |
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
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.
Identifiers
| code_info | Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178…Part No.: 03.501.080 with multiple 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0114-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.