Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0992-2014 — 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.

U.S. FDA — Device Enforcement · United States · 2014-01-27 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0992-2014
Date of alert: 2014-01-27
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Synthes, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-0992-2014 — 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.

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