MicroPort Orthopedics Inc.: Device Recall

Recall #Z-2244-2024 · 05/03/2024

Class II: Risk

Recall Details

Recall Number: Z-2244-2024
Classification: Class II
Product Type: Device
Recalling Firm: MicroPort Orthopedics Inc.
Status: Ongoing
Date Initiated: 05/03/2024
Location: Arlington, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 40 units

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.

Product Description

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

Distribution Pattern

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

Other Recalls by MicroPort Orthopedics Inc.

Class II: Risk 12/19/2025

Due to products not having FDA Premarket authorization to be distributed within the United States.
Class II: Risk 10/29/2024

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.

View all recalls by MicroPort Orthopedics Inc. →

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.