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FDAMarch 30, 2018device

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 9 MM, REF 71453121 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

What to do

FDA enforcement status: Terminated

Brands named

smith nephewsmithsmith nephew

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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