Recall Z-2638-2016— Medtronic Sofamor Danek USA Inc

Name: FDA recall Z-2638-2016
Creator: U.S. Food and Drug Administration
Published: 2016-07-18

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek USA Inc, initiated 2016-07-18, terminated 2016-11-22. It names one FDA 510(k) clearance: K150496. Product: TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement. Reason: The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler..

Recalling firm: Medtronic Sofamor Danek USA Inc
Classification: Class II
Status: Terminated
Initiated: 2016-07-18
Terminated: 2016-11-22
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K150496 — Total Knee Arthroplasty SystemResponsive Orthopedics, LLC·cleared 2015-06-12

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

TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

Reason for recall

The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.

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