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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
Recall Number Z-1781-2014
Classification Class II
Code Info part number: 03.503.057, lot number 8453237
Product Distributed Qty 14
Reason For Recall 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.

Event Detail

Event Id 68111
Product Type Devices
Status Ongoing
Recalling Firm Synthes, Inc.
City West Chester
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Distribution including the states of CA, CT, FL, GA, NY, SD and TX.
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