Z-0114-2014Class II

Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary...

Name: Z-0114-2014 Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary...
Creator: Synthes USA HQ, Inc.
Published: 2013-08-13
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-08-13 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture... on 2013-08-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0114-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-13
Posted: 2013-10-30
Terminated: 2016-08-18
Recalling firm: Synthes GmbH
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
Product code: JDQ Cerclage, Fixation
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 319
Distribution: Worldwide Distribution - US (nationwide) and country of Mexico.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0114-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0114-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-06	2013-10-30

Product code JDQ

K110789Class IISynthes Sternal Zipfix SystemSynthes (Usa) / cleared 2011-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)