FDAClass IIJune 18, 2014

Synthes Matrix Mandible Short Cut Plate Cutter Synthes recall

Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.

Why was Synthes Matrix Mandible Short Cut Plate Cutter Synthes recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

part number: 03.503.057, lot number 8453237

Product
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
Recalling firm
Synthes, Inc.
Quantity
14
Distribution
US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.
Recall date
June 18, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls