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Recall Observatory FDA recall evidence

Device product

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

Z-1781-2014

April 22, 2014

Class II

Product summary

Firm
Synthes, Inc.
Event
Event 68111
Status
Terminated
Classification
Class II
Quantity
14
Official record key
device-enforcement:Z-1781-2014

Official wording

Reason: 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.

Code information: part number: 03.503.057, lot number 8453237

Distribution pattern: US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.