Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumbar pedical screw system designed to provide fl

FDA device recall Z-0384-2014 · posted 2013-11-22 · Terminated

Recall details

Recalling firm

Synthes USA HQ, Inc.

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.

Action taken

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: FieldAction@synthes.com, even if you do not have the affected product. If you have questions, please call 610-719-5450.

Root cause

Labeling design

Status

Terminated

Product code

LXH

Quantity affected

634

Distribution

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

Date initiated

2013-07-31

Date posted

2013-11-22

Date terminated

2015-08-31

Location

West Chester, PA