Synthes Application Instrument Sternal Zip Flex System recallZ-0114-2014 · Synthes USA HQ, Inc. · initiated Aug 13, 2013
Class II Terminated All recalls posted in October 2013
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 HQ, Inc. 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
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.
FDA root cause category: Labeling False and Misleading
What the company is doing
Synthes sent a Urgent Medical Device Notification dated August 13, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken: This notification is to make you aware of the issue and the importance of completely releasing the tensioning trigger before cutting the implant. Please take the following action: "To ensure your receipt and understanding of this information, Please complete the verification section of this letter and return to Synthes by either of the following methods: " Fax: 1-888-352-9616 or " Scan/email: [email protected] If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant.
Recall details
- Recall number
- Z-0114-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 13, 2013
- Posted by the FDA
- Oct 30, 2013
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 319
- Product code
- JDQ
- FDA submissions
- K110789
- Distribution
- Worldwide Distribution - US (nationwide) and country of Mexico.
Product description
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
Code information (models, lots, serial numbers)
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
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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