Events

Recall of Synthes External Fixation Systems (Small, Medium, Large and DO)

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
    68072
  • Event Risk Class
    Class 2
  • Event Number
    Z-1833-2014
  • Event Initiated Date
    2014-04-10
  • Event Date Posted
    2014-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126902
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Reason
    Labeling changes have been made related to mr (magnetic resonance imaging) conditions as a result of changes in required protocols to designate a product mr safe, mr conditional, or mr unsafe.
  • Action
    Synthes sent an Urgent Notice dated April 10, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: All Synthes External Fixation devices should be treated as MR Conditional. " Synthes asks that you review the information contained in this Labeling Notification and complete the Verification Section located on Page 3. " Discard outdated revisions of the Technique Guides noted in the table below. " Update your records with updated Labeling Infonnation. " Forward this Medical Device Labeling Update to anyone in your facility that needs to be infonned, especially those personnel that conduct MR testing. " If the Verification Fonn is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in pg. 3. " Updated product literature can be located on the Synthes website at http://www.syntheskyo.com/trauma kyo/home/home.htm. " Please see the attached inseii for current conditions for use in the MR environment. " Maintain a copy of this notice. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-719-5000.

Device

Synthes External Fixation Systems (Small, Medium, Large and DO)
  • Model / Serial
    All lot numbers of multiple part numbers:293.35 293.36 293.40 293.41 293.42 293.44 293.45 293.46 293.47 293.48 293.48L 293.48X 293.49 293.50 293.51 293.52 293.53 293.54 293.58 293.59 293.62 293.63 293.67 293.68 293.69 293.72 293.73 293.74 293.78 293.83 293.88 293.93 294.30 294.30SHA 294.43 294.43SHA 294.44 294.44SHA 294.45 294.455 294.45SHA 294.46 294.46SHA 294.48 294.52 294.52SHA 294.53SHA 294.54 294.54SHA 294.55 294.55SHA 294.56 294.56SHA 294.57 294.57SHA 294.65 294.66 294.67 294.67SHA 294.68 294.68SHA 294.71 294.72 294.73 294.73SHA 294.74 294.74SHA 294.75 294.75SHA 294.76 294.767 294.768 294.769 294.769SHA 294.76SHA 294.771 294.771SHA 294.772 294.772SHA 294.773 294.774 294.775 294.775SHA 294.776 294.776SHA 294.777 294.777SHA 294.778 294.778SHA 294.779 294.779SHA 294.782 294.782SHA 294.783 294.783SHA 294.784 294.784SHA 294.785 294.785SHA 294.786 294.786SHA 294.788 294.788SHA 294.792 294.792SHA 294.793 294.793SHA 294.794 294.794SHA 294.795 294.795SHA 294.796 294.796SHA 294.798 294.798SHA 494.769 494.771 494.771SHA 494.772 494.772SHA 494.774 494.775 494.775SHA 494.776 494.776SHA 494.777 494.777SHA 494.778 494.778SHA 494.779 494.779SHA 494.782 494.782SHA 494.783 494.783SHA 494.784 494.784SHA 494.786 494.786SHA 494.788 494.788SHA 494.792 494.793 494.794 494.795 494.796 494.798 294.950 293.790 293.840 293.890 293.940 390.002 390.003 390.004 390.005 390.006 390.007 390.008 390.009 390.010 390.011 390.012 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 494.785 494.785SHA 390.041 390.042 395.60 395.61 395.62 395.63 395.64 395.65 395.66 395.67 395.680 395.681 395.682 395.685 395.686 395.687 395.688 03.301.010s 03.301.011s 03.301.012s 03.301.013s
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
  • 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