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Terminated

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.

FDA Recall Z-0992-2014 · Posted 2014-02-19

Recalling FirmSynthes, Inc.
Recall StatusTerminated
Product CodeFZX
Date Initiated2014-01-27
Date Terminated2015-07-20
Product Quantity12

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.

Firm Action

A recall letter, dated January 27, 2014, was sent to end users and sales consultants.

Root Cause

Process control

Distribution Pattern

US distribution to MI, TX, and CA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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