BEUDAMED
    FDA Recall Terminated

    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.

    Recall: Z-2199-2013 · Initiated August 13, 2013

    Recall

    Recall Number
    Z-2199-2013
    Event Number
    66057
    Firm
    Tornier, Inc
    FEI Number
    3000718467
    Product Code
    HTZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 13, 2013
    Posted
    September 13, 2013
    Terminated
    March 3, 2015
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109

    Description

    AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.

    Reason

    Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R

    Action

    Tornier sent an "Urgent Medical Device Recall" letter dated August 12, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customer were advised to cease further use and distribution of the product and to contact all end users. Also requested the completion and return of the attached questionnaire via fax to 952-236-4007, e-mail to [email protected] or using the envelope provided. We apologize for the incovenience and thank you in advance for your cooperation in this matter. If you have any questions please contact our Customer Service Department at 1-888 494-7950.

    Distribution

    .Worldwide Distribution - USA including Puerto Rico and the states of AL, AZ, CA, CO,CT, FL, GA, IL, KY, MD, MA, MI, MN, NE, NJ, NC, OH, OR, PA and TX., and the countries of CANADA, MEXICO, HONG KONG, SOUTH AFRICA, ARGENTINA, COLOMBIA, ISRAEL, AUSTRALIA, BELGIUM, FINLAND,FRANCE, GERMANY, ITALY, NETHERLANDS, SLOVENIA, SPAIN, SWITZERLAND and UNITED KINGDOM

    Quantity

    2,298 (1045 US, 1253 OUS)