Z-2244-2024 Class II Ongoing

Recalled by MicroPort Orthopedics Inc. — Arlington, TN

Recall Details

Product Type
Devices
Report Date
July 10, 2024
Initiation Date
May 3, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
40 units

Product Description

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 Pattern

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

Code Information

UDI: Part EFSRN3PL: Primary DI Number M684EFSRN3PL1, Part EFSRN4PR: Primary DI Number M684EFSRN4PR1; lot Number's: MP1982097, MP1982170; Catalog Number(s): EFSRN3PL, EFSRN4PR