LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
FDA Recall #Z-1507-2020 — Class II — December 19, 2019
Product Description
LEGION PS High Flex XLPE size 5-6 9mm Articular Insert
Reason for Recall
LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part
Recalling Firm
Smith & Nephew, Inc. — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
29 units
Distribution
USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).
Code Information
Lot Number 19FM12500; Product Number 71453221.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated