Device 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.
Z-0992-2014
Product summary
- Firm
- Synthes, Inc.
- Event
- Event 67396
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12
- Official record key
device-enforcement:Z-0992-2014
Official wording
Reason: 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.
Code information: part No. 03.503.043, lot #7908431
Distribution pattern: US distribution to MI, TX, and CA.
Derived failure modes
-
Unknown
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.