RecallRadar

FDA Device recall Z-0992-2014

Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery

On 2014-02-26 the FDA classified a Class II recall of Synthes Matrix Mandible Short Threaded Drill Guide intended for oral, maxillofacial surgery by Synthes, citing 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.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0992-2014
ClassificationClass II
Statusterminated
Initiated2014-01-27
Published2014-02-26
Last updated2026-09-13 11:53 UTC
CompanySynthes
DistributionCA, MI, TX

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.

Reason

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.

Identifiers

code_infopart No. 03.503.043, lot #7908431

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0992-2014%22

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