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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