BEUDAMED
    FDA Enforcement Class II Terminated

    Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

    Recall: Z-2499-2019 · Reported September 18, 2019

    Enforcement

    Recall Number
    Z-2499-2019
    Event ID
    83520
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Exactech, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2019
    Initiation Date
    July 24, 2019
    Classification Date
    September 10, 2019
    Termination Date
    May 31, 2023
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630, United States

    Description

    Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.

    Reason

    The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.

    Code Info

    Catalog Number 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001

    Distribution

    US distribution to AR, CA, FL, IL, IN, NY, SC, TX.

    Quantity

    22 devices