FDA-Device2018-05-30Class II
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.
Smith & Nephew, Inc.
Hazard
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
Sold states
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
Affected count
N/A
Manufactured in
1450 E Brooks Rd, N/A, Memphis, TN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1906-2018Don't want to check this manually?
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