smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 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.
The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.
US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1904-2018