Recall Z-1249-2015— Microport Orthopedics INC.

Name: FDA recall Z-1249-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-02

Class II · Terminated

Class II FDA medical device recall by Microport Orthopedics INC., initiated 2015-02-02, terminated 2015-03-19. It names one FDA 510(k) clearance: K093552. Product: EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.. Reason: Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product..

Recalling firm: Microport Orthopedics INC.
Classification: Class II
Status: Terminated
Initiated: 2015-02-02
Terminated: 2015-03-19
Firm location: Arlington, TN, United States

510(k) clearances named in this recall

1 on FDA's record

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 BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.

Reason for recall

Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

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