PlainRecalls
FDA Devices Moderate Class II 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.

Reported: February 26, 2014 Initiated: January 27, 2014 #Z-0992-2014

Product Description

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 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.

Details

Recalling Firm
Synthes, Inc.
Units Affected
12
Distribution
US distribution to MI, TX, and CA.
Location
West Chester, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Synthes, Inc.. Units affected: 12.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-0992-2014.