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.
FDA Recall Z-0384-2014 · Posted 2013-11-22
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Recalling FirmSynthes USA HQ, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-07-31
Date Terminated2015-08-31
Product Quantity634
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.
Firm Action
The firm, Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 31, 2013 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove the affected lots from stock; If you do have the affected devices, contact Synthes at 1-800-479-6329 to obtain the RA# and return the product to with completed form to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132; complete and sign the Return Receipt Requested form via fax at 1-888-731-7955 or email to: [email protected], even if you do not have the affected product.
If you have questions, please call 610-719-5450.
Root Cause
Labeling design
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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