Events

Recall of Device Recall Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Col

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA HQ, 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
    64271
  • Event Risk Class
    Class 2
  • Event Number
    Z-1016-2013
  • Event Initiated Date
    2013-01-11
  • Event Date Posted
    2013-03-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115737
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    The dens instrument set has been designed to facilitate the anterior internal fixation of the dens (odontoid process). there are currently no screws specifically indicated to treat dens fractures via anterior screw fixation therefore the affected product will be removed.
  • Action
    Synthes sent an Urgent Notice Medical Device Recall letter dated January 11, 2013, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory, remove the recalled product from use and return it to Synthes. Customers were asked to completed the attached verification Section at the end of the letter by checking the appropriate box indicating that no affected product had been located and fax to 610-251-9005. For questions customers were instructed to call 610-719-5450 or email at FieldAction@synthes.com. For questions regarding this recall call 610-719-5000.

Device

Device Recall Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known a...
  • Model / Serial
    Part number 687.030, All Lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IL, KS, KY, LA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, TN, TX, VA, VT, WI, WV, and WY.
  • Product Description
    Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) || The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

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