Events

Recall of Device Recall Synthes Minimally Invasive Reduction Screw System (MIRS)

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
    62773
  • Event Risk Class
    Class 2
  • Event Number
    Z-0001-2013
  • Event Initiated Date
    2012-06-18
  • Event Date Posted
    2012-10-01
  • 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=111690
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Reason
    Synthes is initiating a medical device labeling correction following a detailed review of the current labeling in response to reported complaints. synthes has identified technique measures and has updated the labeling associated with this system. the labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.
  • Action
    SYNTHES sent an Urgent Medical Device Labeling Correction letter dated June 18, 2012. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to replace the previous version of the labeling with the new labeling provided. In addition, they can access an electronic version of the labeling by accessing Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J11031-B located at the bottom right corner of the back cover. To confirm their receipt and understanding of the information contained in the letter, the recall package also included a response form to be completed by consignee and returned to Synthes.by Fax: 610-251-9005 or Scan/email: FieldAction@Synthes.com. Customers with questions were asked to call 1-800-620-7025, ext 5403 or contact their Synthes Spine Sales Consultant. For questions regarding this recall call 610-719-5377. The firm initiated this recall action on June 18, 2012 by sending an Urgent Medical Device Labeling Correction letter to all accounts. The updated labeling was Included with the notification letter.

Device

Device Recall Synthes Minimally Invasive Reduction Screw System (MIRS)
  • Model / Serial
    Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
  • Product Description
    MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. || The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
  • 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