Events

Recall of Device Recall Soft Face "No Bounce" Mallet

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Signal Medical Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76509
  • Event Risk Class
    Class 2
  • Event Number
    Z-1834-2017
  • Event Initiated Date
    2017-02-20
  • Event Date Posted
    2017-04-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153400
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Mallet, surgical, general & plastic surgery - Product Code GFJ
  • 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 SignalMedical2017@gmail.com or faxing to 810-364-7072. The firm has attached the revised labeling to the letter.

Device

Device Recall Soft Face "No Bounce" Mallet

Manufacturer

Signal Medical Corporation
  • Manufacturer Address
    Signal Medical Corporation, 400 Pyramid Dr, Marysville MI 48040-2463
  • Manufacturer Parent Company (2017)
    Signal Medical Corporation
  • Source
    USFDA