Synthes Application Instrument for Sternal ZIPFIX recallZ-2475-2015 · Synthes (USA) Products LLC · initiated Jul 22, 2015
Class II Terminated All recalls posted in August 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes (USA) Products LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The end cap may loosen and detach making the instrument non-functional. No injuries reported.
FDA root cause category: Device Design
What the company is doing
Urgent recall notification letters, dated July 22, 2015 were sent to end users and consultants to inform them of the issue, the associated risks, and provided instructions to return affected devices along with the response form.
Recall details
- Recall number
- Z-2475-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jul 22, 2015
- Posted by the FDA
- Aug 27, 2015
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 451
- Product code
- JDQ
- FDA submissions
- K110789
- Distribution
- Nationwide and internationally to Canada.
Product description
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
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
4 devices cleared under K110789 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ZipFix 03.501.080Synthes GmbH · CERCLAGE, FIXATION236 reports
- ZipFix 08.501.001.01SSynthes GmbH · CERCLAGE, FIXATION39 reports
- ZipFix 08.501.001.05SSynthes GmbH · CERCLAGE, FIXATION29 reports
- ZipFix 08.501.001.20SSynthes GmbH · CERCLAGE, FIXATION23 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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