FDAFDA · Food and drugs·Recall number 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.
Published February 26, 2014 · Recall initiated: January 27, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- US distribution to MI, TX, and CA.
- Lot
- part No. 03.503.043, lot #7908431
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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