Synthes Application Instrument for Sternal ZIPFIX.… recallZ-0276-2016 · Synthes (USA) Products LLC · initiated Oct 19, 2015
Class II Terminated All recalls posted in November 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
Certain lots of the Application Instrument for Sternal ZIPFIX that were previously recalled on August 19, 2015 and subsequently repaired and returned to customers between August 26, 2015 and September 23, 2015. The screws on the repaired instruments have the potential to break or loosen. DePuy Synthes is requesting the return of the repaired device in exchange for a new device.
FDA root cause category: Device Design
What the company is doing
Communication to the accounts having record of receiving this product was sent on October 19, 2015.
Recall details
- Recall number
- Z-0276-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Oct 19, 2015
- Posted by the FDA
- Nov 14, 2015
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 267
- Product code
- JDQ
- FDA submissions
- K110789
- Distribution
- Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
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)
Synthes Application Instrument for Sternal ZIPFIX, Part Number 03.501.080. Lot Numbers 3783913, 7516728, 7606881, 7659168, 7666085, 7671934, 7689244, 7694377, 7720599, 7738572, 7738573, 7740498, 7767497, 7803768, 7806881, 7818677, 7818682, 7821672, 7827088, 7831855, 7833606, 8068078, 8130898, 8145793, 8207769, and 8215969.
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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