BEUDAMED
    FDA Recall Terminated

    VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.

    Recall: Z-0277-2014 · Initiated August 28, 2013

    Recall

    Recall Number
    Z-0277-2014
    Event Number
    66199
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 28, 2013
    Posted
    November 14, 2013
    Terminated
    April 30, 2015
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    VerSys Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.

    Reason

    Based on a review of historic packaging validations, it was determined that a subset of product packaged in one of the clean rooms at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing (seal integrity and seal strength) to provid

    Action

    Removal of the subject devices from the field including distributor and hospital inventories. Distributors and Risk Managers and Surgeons at hospitals that received a direct shipment from Zimmer or its Distributors received a notification on 09/19/2013.

    Distribution

    Worldwide distribution: US (Nationwide) including Puerto Rico and Virgin Islands; and countries of: Australia, Algeria, Belgium, Bolivia, Canada, Canary Islands, Chile, Croatia, Finland, France, Germany, Greece, Guatemala, Honduras, India, Israel, Italy, Japan, Jordan, Lima-Peru, Malaysia, Morocco, Nicaragua, Portugal, Saudi Arabia, Seoul Korea, Serbia, Singapore, South Africa, Spain, Switzerland, Turkey, Utd.Arab.Emir., United Kingdom, and Venezuela.

    Quantity

    12866 units