Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

Recall date
December 19, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1507-2020
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).

Why it was recalled

LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part

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

What was recalled

LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

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