BEUDAMED
    FDA Recall Terminated

    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    Recall: Z-2619-2017 · Initiated May 12, 2017

    Recall

    Recall Number
    Z-2619-2017
    Event Number
    77252
    Firm
    DePuy Mitek, Inc., a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 12, 2017
    Terminated
    October 3, 2018
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    DePuy Mitek LATARJET EXPERIENCE Extraction Driver Product Code: 288216 Product Usage: The Latarjet Cortical Screw set is intended to treat recurrent shoulder instability by supporting the anteroinferior glenoid with a bony graft

    Reason

    Combo Screw Driver (Product Code 288211) tip has the increased potential to break intra-operatively when being used at an angle off-axis to screw

    Action

    DePuy Mitek issued recall letter dated May 12, 2017 advising of the problem and requesting return of the product. A Response Form is to be completed and returned. Questions: contact your DePuy Synthes Mitek Sales Consultant or Carolyn Somerville, DePuy Mitek, Inc. (via telephone: 508.828.3647 Fax: 508.828.3762 or via email: [email protected]).

    Distribution

    US: AZ, CA, CO, GA, MA, MI, OH, WA Foreign: Austria, Australia, Belgium, France, Germany, Spain, Switzerland, Netherlands, Poland, UK

    Quantity

    115 units