MicroPort Orthopedics Inc.: Device Recall

Recall #Z-0699-2025 · 10/29/2024

Class II: Risk

Recall Details

Recall Number
Z-0699-2025
Classification
Class II
Product Type
Device
Recalling Firm
MicroPort Orthopedics Inc.
Status
Ongoing
Date Initiated
10/29/2024
Location
Arlington, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
32

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.

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

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.