Recall Z-2244-2024— MicroPort Orthopedics Inc.

Name: FDA recall Z-2244-2024
Creator: U.S. Food and Drug Administration
Published: 2024-05-03

Class II · Ongoing

Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2024-05-03. It names 2 FDA 510(k) clearances: K102380, K093552. Product: EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.. Reason: 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..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class II
Status: Ongoing
Initiated: 2024-05-03
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

2 on FDA's record

K102380 — EVOLUTION MP TOTAL KNEE SYSTEMWrightmedicaltechnologyinc·cleared 2011-01-07
K093552 — EVOLUTION MP TOTAL KNEE SYSTEMWrightmedicaltechnologyinc·cleared 2010-03-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.