Z-0699-2025 Class II Ongoing

Recalled by MicroPort Orthopedics Inc. — Arlington, TN

Recall Details

Product Type
Devices
Report Date
December 25, 2024
Initiation Date
October 29, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32

Product Description

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

Reason for Recall

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.

Distribution Pattern

OUS: CN, GR, ES, ZA, FR, JP, IT

Code Information

REF/UDI-DI/Lot/Expiration: EFSRP5PR/M684EFSRP5PR1/2007116/2032-05-06. EFSRN6PL/M684EFSRN6PL1/MP2002559/2032-05-06.