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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