Home / Recalls / Synthes USA HQ, Inc. / Z-0384-2014

Z-0384-2014 Class II Terminated

Recalled by Synthes USA HQ, Inc. — West Chester, PA

Recall Details

Product Type
Devices
Report Date
December 4, 2013
Initiation Date
July 31, 2013
Termination Date
August 31, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
634

Product Description

Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide flexibility biomechanical performance and a solution to complex posterior pathological challenges.

Reason for Recall

Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction Insert malfunctioned causing pieces to break off. Once there is a breakage to the Reduction Insert it will not allow the instrument to function as required.

Distribution Pattern

Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.

Code Information

Item Lot Number Number 03.632.008 4833901 03.632.008 6284014 03.632.008 6284015 03.632.008 6377412 03.632.008 6390270 03.632.008 6390308 03.632.008 6390309 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6558995 03.632.008 6559002 03.632.008 6583188 03.632.008 6583189 03.632.008 6603334 03.632.008 6603335 03.632.008 6624550 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635 03.632.008 4833901 03.632.008 6445711 03.632.008 6455761 03.632.008 6455786 03.632.008 6530998 03.632.008 6548747 03.632.008 6603334 03.632.008 6603335 03.632.008 6676663 03.632.008 6703414 03.632.008 6706733 03.632.008 6718634 03.632.008 6718635

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