FDAFDA · Food and drugs·Recall number Z-1781-2014
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
Published June 18, 2014 · Recall initiated: April 22, 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
It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.
- Lot
- part number: 03.503.057, lot number 8453237
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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