FDA-Device2020-03-25Class II

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

Smith & Nephew, Inc.
Hazard

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

Sold states
USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
Affected count
29 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1507-2020

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