Events

Recall of Synthes Mandible External Fixator

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

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
    69533
  • Event Risk Class
    Class 2
  • Event Number
    Z-1009-2015
  • Event Initiated Date
    2014-10-17
  • Event Date Posted
    2015-01-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130880
  • 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
    External mandibular fixator and/or distractor - Product Code MQN
  • Reason
    Under new testing protocols for mr environment safety and compatibility, metal devices are no longer designated mr safe. some components in the cmf mandible external fixator systems were labeled and/or etched with information indicating they are mr safe. they can no longer be labeled mr safe.
  • Action
    Urgent notices of medical device labeling updates, dated October 17, 2014 and October 24, 2014 were sent to end users and sales consultants, which described the product, problem, and action to be taken. These consignees were instructed to inspect inventory and remove out-dated labeling inserts and replace with updated labeling information.

Device

Synthes Mandible External Fixator
  • Model / Serial
    All lots of part nos.:  04.305.003 04.305.004 04.305.005 04.305.010 04.305.011 04.305.012 03.305.006 04.305.100 04.305.101 04.305.102 04.305.103 04.305.128 04.305.130 04.305.134 04.305.138 04.305.140 04.305.142 03.305.105
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    The Synthes Mandible External Fixator; all lots of part nos.: || 04.305.003 || 04.305.004 || 04.305.005 || 04.305.010 || 04.305.011 || 04.305.012 || 03.305.006 || 04.305.100 || 04.305.101 || 04.305.102 || 04.305.103 || 04.305.128 || 04.305.130 || 04.305.134 || 04.305.138 || 04.305.140 || 04.305.142 || 03.305.105 || 03.305.500 || 03.305.500S || Intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.
  • Manufacturer
    Synthes, Inc.

Manufacturer

Synthes, Inc.
  • Manufacturer Address
    Synthes, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA