Reported Dec 4, 2013 · Terminated

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

Synthes USA HQ, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417

Is this the product you have?

  • 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.
Lot codes and dates
  • Item Lot Number Number

    74 of 74 codes

    • 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
Amount recalled
634

This recall covers 16 products

The agency filed one notice per product. You are reading one of them; the other 15 are below.

3 more are in the archive.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 31, 2015 · Data as of Sep 19, 6:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.