FDA-Device2013-12-04Class II
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.
Synthes USA HQ, Inc.
Hazard
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.
Sold states
Worldwide distribution: US (nationwide) and countries of Canada and Switzerland.
Affected count
634
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0384-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief