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Recall Observatory FDA recall evidence

Device product

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

Z-1507-2020

December 19, 2019

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 84647
Status
Terminated
Classification
Class II
Quantity
29 units
Official record key
device-enforcement:Z-1507-2020

Official wording

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

Code information: Lot Number 19FM12500; Product Number 71453221.

Distribution pattern: USA: TN, NC, CA,OR, NM, TX, PA, MI, LA, DA, IL. Int'l: IT (Italy), NL (Netherlands), RO (Romania), PR (Puerto Rico).

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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