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
03.632.008483390103.632.008628401403.632.008628401503.632.008637741203.632.008639027003.632.008639030803.632.008639030903.632.008644571103.632.008645576103.632.008645578603.632.008653099803.632.008654874703.632.008655899503.632.008655900203.632.008658318803.632.008658318903.632.008660333403.632.008660333503.632.008662455003.632.008667666303.632.008670341403.632.008670673303.632.008671863403.632.008671863503.632.008483390103.632.008644571103.632.008645576103.632.008645578603.632.008653099803.632.0086548747
- Item Lot Number Number
- 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.
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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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