Recall Z-1225-2022— MicroPort Orthopedics Inc.

Name: FDA recall Z-1225-2022
Creator: U.S. Food and Drug Administration
Published: 2022-05-04

Class II · Terminated

Class II FDA medical device recall by MicroPort Orthopedics Inc., initiated 2022-05-04, terminated 2024-01-16. It names one FDA 510(k) clearance: K123434. Product: PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK. Reason: One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body..

Recalling firm: MicroPort Orthopedics Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-05-04
Terminated: 2024-01-16
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K123434 — PROFEMUR Z CLASSIC STEMSWrightmedicaltechnologyinc·cleared 2013-02-05

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

PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK

Reason for recall

One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.

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