Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 designed for use in patients…

Recall date
March 30, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1905-2018
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 11 MM, REF 71453122 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.

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