BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1834-2017 · Initiated February 20, 2017

    Recall

    Recall Number
    Z-1834-2017
    Event Number
    76509
    Firm
    Signal Medical Corporation
    FEI Number
    3002477077
    Product Code
    GFJ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 20, 2017
    Posted
    April 17, 2017
    Terminated
    August 25, 2017
    Address
    400 Pyramid Dr, Marysville, MI, 48040-2463

    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.

    Action

    On 2/20/2016, URGENT: MEDICAL DEVICE RECALL notifications dated February 10, 2017 were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are to retain the notice and replace the old Instructions For Use with the updated version. Also, they are to acknowledge receipt of the instructions by signing the notice and emailing to [email protected] or faxing to 810-364-7072. The firm has attached the revised labeling to the letter.

    Distribution

    Nationwide Distribution.

    Quantity

    1,640