Z-0384-2014Class II

Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to...

Name: Z-0384-2014 Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to...
Creator: Synthes USA HQ, Inc.
Published: 2013-07-31
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2013-07-31 / Terminated / root cause: labeling and UDI

FDA source

Synthes USA HQ, Inc. began a recall of Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and... on 2013-07-31. FDA classified it as Class II and gives the reason as "Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the...". 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-0384-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-31
Posted: 2013-11-22
Terminated: 2015-08-31
Recalling firm: Synthes GmbH
Product: Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm, Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 31, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from stock; If you do have the affected devices, contact Synthes at 1-800-479-6329 to obtain the RA# and return the product to with completed form to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; complete and sign the Return Receipt Requested form via fax at 1-888-731-7955 or email to: [email protected], even if you do not have the affected product. If you have questions, please call 610-719-5450.
Quantity in commerce: 634
Distribution: Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.
Product codes and lots: Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0384-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0384-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-04	2013-11-22

Product code LXH

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