Z-0276-2016Class II

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

Name: Z-0276-2016 Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary...
Creator: Synthes (USA) Products LLC
Published: 2015-10-19
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2015-10-19 / 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 2015-10-19. FDA classified it as Class II and gives the reason as "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...". 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-0276-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-19
Posted: 2015-11-14
Terminated: 2016-08-26
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: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Communication to the accounts having record of receiving this product was sent on October 19, 2015.
Quantity in commerce: 267
Distribution: Distributed in the states of KY, UT, CA, WI, OH, CO, IL, TX, OK, WA, MI, LA, MA, PA and NE.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0276-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0276-2016	Class II	Terminated	Voluntary: Firm initiated	2015-11-25	2015-11-13

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)