Z-0992-2014Class II

Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and...

Name: Z-0992-2014 Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and...
Creator: Synthes, Inc.
Published: 2014-01-27
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2014-01-27 / Terminated / root cause: manufacturing process

FDA source

Synthes, Inc. began a recall of Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of... on 2014-01-27. FDA classified it as Class II and gives the reason as "One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0992-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-27
Posted: 2014-02-19
Terminated: 2015-07-20
Recalling firm: Synthes GmbH
Product: Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery; trauma and reconstructive surgery, specifically for fractures of the subcondylar region of the mandible and fractures of the condylar basis region of the mandible.
Product code: FZX Guide, Surgical, Instrument
Reason for recall: One lot of Matrix Mandible Short Threaded Drill Guides (part No. 03.503.043) has a gray colored band instead of a green colored band as pictured in the Technique Guide.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall letter, dated January 27, 2014, was sent to end users and sales consultants.
Quantity in commerce: 12
Distribution: US distribution to MI, TX, and CA.
Product codes and lots: part No. 03.503.043, lot #7908431

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0992-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0992-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-26	2014-02-19

Product code FZX

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)