Z-0391-2014Class II

Synthes Matrix 5.5.mm Left and Right Coronal Bender

Name: Z-0391-2014 Synthes Matrix 5.5.mm Left and Right Coronal Bender
Creator: Synthes USA HQ, Inc.
Published: 2013-06-22
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-06-22 / Terminated / root cause: design

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix... on 2013-06-22. FDA classified it as Class II and gives the reason as "A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System". 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-0391-2014
Classification: Class II
Status: Terminated
Initiated: 2013-06-22
Posted: 2013-11-26
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes Matrix 5.5.mm Left and Right Coronal Bender Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
Product code: HXP Instrument, Bending Or Contouring
Reason for recall: A complaint was received of the tips of the Matrix 5.5.mm Left and Right Coronal Bender breaking while bending a spinal rod component of the Matrix System.
Root cause tag: design
FDA root cause: Component design/selection
Action: Synthes sent an Urgent Notice: Medical Device Recall letter dated June 22, 2013 to users and sales reps. The letter identified the affected product, problem and actions to be taken. For questions call 610-719-5450.
Quantity in commerce: 209
Distribution: Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
Product codes and lots: Parts 03.632.040 and 03.632.041 with various lot nos. Item Lot Number Number 03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995 Item Lot Number Number 03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0391-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0391-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-25

Product code HXP

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)