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.
This recall has been terminated (originally issued February 19, 2014).
- Company
- Synthes, Inc.
- Recall Initiated
- January 27, 2014
- Posted
- February 19, 2014
- Terminated
- July 20, 2015
- Recall Number
- Z-0992-2014
- Quantity
- 12
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
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.
Distribution
US distribution to MI, TX, and CA.
Lot / Code Info
part No. 03.503.043, lot #7908431
Root Cause
Process control
Action Taken
A recall letter, dated January 27, 2014, was sent to end users and sales consultants.
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