—#122359

Product

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 product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Synthes USA HQ, Inc.
Address: 1302 Wrights Ln E, West Chester, Pennsylvania 19380-3417

Distribution

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

Timeline

Recall initiated: 2013-07-31
Posted by FDA: 2013-11-22
Terminated: 2015-08-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122359. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.