FDA recall Z-2244-2024

Product

EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.

Reason for recall

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.

Distribution

International distribution in the country of China. There is no field inventory in the United States for either lot.

Key facts

Status

Ongoing

Initiation date

2024-05-03

Report date

2024-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Arlington, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2244-2024