FDA-Device2024-07-10Class II
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
MicroPort Orthopedics Inc.
Hazard
One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
Sold states
International distribution in the country of China. There is no field inventory in the United States for either lot.
Affected count
40 units
Manufactured in
5677 Airline Rd, N/A, Arlington, TN, United States
Products
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2024Don't want to check this manually?
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