Class 2 Device Recall Synthes Matrix Mandible Short Threaded Drill Guide

• Date Initiated by Firm: January 27, 2014
• Date Posted: February 19, 2014
• Recall Status: Terminated on July 20, 2015
• Recall Number: Z-0992-2014
• Recall Event ID: 67396
• Product Classification: Guide, surgical, instrument - Product Code FZX
• 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.
• Code Information: part No. 03.503.043, lot #7908431
• FEI Number: 3005180112
• Recalling Firm/ Manufacturer: Synthes, Inc.; 1302 Wrights Ln E; West Chester PA 19380-3417
• For Additional Information Contact: Customer Support; 610-719-5000
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.