BEUDAMED
    FDA Enforcement Class II Terminated

    Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.

    Recall: Z-1548-2013 · Reported June 26, 2013

    Enforcement

    Recall Number
    Z-1548-2013
    Event ID
    65212
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2013
    Initiation Date
    May 15, 2013
    Classification Date
    June 17, 2013
    Termination Date
    June 9, 2014
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.

    Reason

    Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.

    Code Info

    Catalog number: 010001814 and lot numbers: 318520 and 644720.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.

    Quantity

    17