BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-1798-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1798-2015
    Event ID
    71253
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    April 22, 2015
    Classification Date
    June 15, 2015
    Termination Date
    March 22, 2016
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    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.

    Code Info

    Part 32-423101 Lot 414930 Part 32-423102 Lot 116490 Part 32-423106 Lot 785220 Part 32-423107 Lot 873780 Part 32-423108 Lot 070420 and 785250 Part 32-423109 Lot 670630 Part 32-423115 Lot 672920 Part 32-423119 Lot 785290 Part 32-423116 Lot 073640 Part 32-423101 Lot 785170 Part 32-423102 Lot 785180 Part 32-423109 Lot 785260 Part 32-423124 Lot 024760 Part 32-423110 Lot 785270

    Distribution

    Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.

    Quantity

    27