BEUDAMED
    FDA Enforcement Class II 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 · Reported June 8, 2016

    Enforcement

    Recall Number
    Z-1900-2016
    Event ID
    73200
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 8, 2016
    Initiation Date
    April 12, 2016
    Classification Date
    June 2, 2016
    Termination Date
    July 24, 2019
    Address
    2320 NW 66th Ct, N/A, Gainesville, FL, 32653-1630, United States

    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.

    Code Info

    Product Code: MRA; Catalog Number 140-01-54, Serial Numbers: 4296076, 4296078, 4296079, Exp. 2/23/2021

    Distribution

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

    Quantity

    3 devices