FDA Device recall Z-2475-2015
Synthes Application Instrument for Sternal ZIPFIX
- FDA Device
- Class II
- terminated
- Published 2015-09-02
On 2015-09-02 the FDA classified a Class II recall of Synthes Application Instrument for Sternal ZIPFIX by Synthes Usa Products, citing the end cap may loosen and detach making the instrument non-functional. No injuries reported.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2475-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-22 |
| Published | 2015-09-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
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
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Identifiers
| code_info | Part Number: 03.501.080 Lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168…Part Number: 03.501.080 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 8209190 8215969 8215999 8241958 8290959 8290968 |
|---|
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-2475-2015%22
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