RecallRadar

FDA Device recall Z-1507-2020

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

On 2020-03-25 the FDA classified a Class II recall of LEGION PS High Flex XLPE size 5-6 9mm Articular Insert by Smith And Nephew, citing LEGION PS High Flex XLPE Articular Insert was packaged with an incorrect part.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1507-2020
ClassificationClass II
Statusterminated
Initiated2019-12-19
Published2020-03-25
Last updated2026-09-13 11:55 UTC
CompanySmith And Nephew
DistributionCA, IL, LA, MI, NC, NM, OR, PA, PR, TN, TX

Product

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

Reason

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

Identifiers

code_infoLot Number 19FM12500; Product Number 71453221.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1507-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.