FDA recall Z-1507-2020

Smith & Nephew, Inc. · Class II · device

Product

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-12-19
Report date: 2020-03-25
Termination date: 2024-09-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Memphis, TN, United States

Primary source

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