FDA-Device2024-12-25Class II
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
MicroPort Orthopedics Inc.
Hazard
Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
Sold states
OUS: CN, GR, ES, ZA, FR, JP, IT
Affected count
32
Manufactured in
5677 Airline Rd, Arlington, TN, United States
Products
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0699-2025Don't want to check this manually?
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