BEUDAMED
    FDA Enforcement Class II Terminated

    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

    Recall: Z-1834-2017 · Reported April 26, 2017

    Enforcement

    Recall Number
    Z-1834-2017
    Event ID
    76509
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Signal Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 26, 2017
    Initiation Date
    February 20, 2017
    Classification Date
    April 17, 2017
    Termination Date
    August 25, 2017
    Address
    400 Pyramid Dr, N/A, Marysville, MI, 48040-2463, United States

    Description

    Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090

    Reason

    Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet.

    Code Info

    All units in distribution

    Distribution

    Nationwide Distribution.

    Quantity

    1,640