Recall Z-0275-2016— Medacta Usa

Name: FDA recall Z-0275-2016
Creator: U.S. Food and Drug Administration
Published: 2015-04-17

Class II · Terminated

Class II FDA medical device recall by Medacta Usa, initiated 2015-04-17, terminated 2017-01-05. It names one FDA 510(k) clearance: K130299. Product: GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery. Reason: Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws..

Recalling firm: Medacta Usa
Classification: Class II
Status: Terminated
Initiated: 2015-04-17
Terminated: 2017-01-05
Firm location: Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K130299 — GMK HINGEMedacta International·cleared 2013-08-15

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

GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery

Reason for recall

Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.

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