Z-1781-2014Class II

Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for...

Name: Z-1781-2014 Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for...
Creator: Synthes, Inc.
Published: 2014-04-22
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-04-22 / Terminated / root cause: design

FDA source

Synthes, Inc. began a recall of Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery on 2014-04-22. FDA classified it as Class II and gives the reason as "It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot". 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-1781-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-22
Posted: 2014-06-11
Terminated: 2015-09-10
Recalling firm: Synthes GmbH
Product: Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
Product code: HTZ Instrument, Cutting, Orthopedic
Reason for recall: It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
Root cause tag: design
FDA root cause: Device Design
Action: Synthes Inc. sent an Urgent Medical Device Recall Notice dated April 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you DO have any of the identified devices, please take the following steps: Contact DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number . Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Return a copy of the Verification Section (page 3 of this letter) to DePuy Synthes by: Fax: 866-324-3731 or Scan/email: [email protected] If you DO NOT have the identified product, please take the following steps: Complete the attached Verification Section at the end of this letter by checking the appropriate box indication that no affecteded product has been located. Please include your name, title, telephone number and signature in the spaces provided this return documentation acknowledges your receipt of medical device removal information. Return the Verification Section (page 3 of this letter) to DePuy Synthes by: Fax: 866-324-3731 or Scan/email: [email protected] Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 3 of the notification. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes sales consultant.
Quantity in commerce: 14
Distribution: US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.
Product codes and lots: part number: 03.503.057, lot number 8453237

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1781-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1781-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-18	2014-06-11

Product code HTZ

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)