BEUDAMED
    FDA Recall Terminated

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

    Recall: Z-1900-2016 · Initiated April 12, 2016

    Recall

    Recall Number
    Z-1900-2016
    Event Number
    73200
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    MRA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 12, 2016
    Terminated
    July 24, 2019
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.

    Reason

    Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.

    Action

    Customers were notified 4/12/2016 with a Product Recall Advisory Notice of affected products.In order to comply with applicable regulations and Exactech policies: " Immediately cease distribution or use of these products. " Extend this information to your accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in your inventory " Complete and Return the attached Recall Inventory Response Form to Exactech, per the instructions provided on the notice itself. According to policy, please contact your Exactech inventory representative within 5 business days to confirm quantities at your location. If you have any inventory restocking questions related to this issue, please contact Kaya Davis at [email protected] or 1-800-392-2832. Please return the products to the following address: Exactech Distribution Center 2411 NW 66th Court Gainesville, Florida 32653 Attention: Kaya Davis [email protected] 352-337-3915 (Fax)

    Distribution

    Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.

    Quantity

    3 devices