Recall Z-0275-2023— MicroPort Orthopedics Inc.

Name: FDA recall Z-0275-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-28

Class II · Ongoing

Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2022-10-28. It names 2 FDA 510(k) clearances: K102380, K093552. Product: EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base. Reason: One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-28
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 Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base

Reason for recall

One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.

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