Recall Z-1798-2015— Biomet, Inc.

Name: FDA recall Z-1798-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-22

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-04-22, terminated 2016-03-22. It names one FDA 510(k) clearance: K042093. Product: Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.. Reason: The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-04-22
Terminated: 2016-03-22
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K042093 — VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGSBiomet, Inc.·cleared 2004-11-01

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

Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

Reason for recall

The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the same side as the keel marked LM and the L on the same side as the keel marked RM. This is incorrect. Please note that the keel is not etched on this side by design.

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