Z-2475-2015Class II

Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary...

Name: Z-2475-2015 Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary...
Creator: Synthes (USA) Products LLC
Published: 2015-07-22
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-07-22 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or... on 2015-07-22. FDA classified it as Class II and gives the reason as "The end cap may loosen and detach making the instrument non-functional. No injuries reported". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2475-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-22
Posted: 2015-08-27
Terminated: 2016-08-18
Recalling firm: Synthes (USA) Products LLC
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
Product code: JDQ Cerclage, Fixation
Reason for recall: The end cap may loosen and detach making the instrument non-functional. No injuries reported.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 451
Distribution: Nationwide and internationally to Canada.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2475-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2475-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-02	2015-08-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)