BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1548-2013 · Initiated May 15, 2013

    Recall

    Recall Number
    Z-1548-2013
    Event Number
    65212
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    PAO
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    May 15, 2013
    Posted
    June 17, 2013
    Terminated
    June 9, 2014
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    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.

    Action

    On 5/15/2013 an URGENT MEDICAL DEVICE RECALL notification was sent to all consignees detailing to immediately locate and discontinue use of the product and return to Biomet. The following actions are REQUIRED: -Immediately locate and remove the identified device(s) listed below from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . -Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority carrier for your shipment. - If you have further distributed this product. you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices.

    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