Recall of Device Recall Spinous Process Clamp

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Navigation, 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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Status
    Open, Classified
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Orthopedic stereotaxic instrument - Product Code OLO
  • Reason
    Potential for spinal clamps to be damaged when opened beyond intended limits, either no opening once attached to a patient's spinous process or leaving a component behind in the patient's body following breakage.
  • Action
    Medtronic sent an Urgent Medical Device Correction letter dated June 27, 2017, to all affected consignees. The letter notifies consignees of the product correction and requests that practitioners follow the attached use instructions for devices. Practitioners are to identify product damage before each procedure by opening and closing the device jaw with the T-handle. It is instructed that practitioners not continue turning the screw if resistance is met, as this may break the washer. Clamps are not to be used if the jaws remain closed when attempting to open a clamp or if the clamp screw back is out of the clamp. It is asked that this check is done to all inventory and any damaged product is to be reported to Medtronic at 1-800-595-9709 and quarantined. Revised product is available. Consignees are asked to complete and return the provided Consignee Response Form by email to the firm at or by fax to 651-367-7075. Any questions can be directed to 1-800-595-9709.


  • Model / Serial
    P/N 9734715, 9734715K
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, AD, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, & WY. Foreign: Albania, Australia, Bangladesh, Belgium, Bulgaria, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Kenya, Latvia, Luxembourg, Malaysia, Martinique, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, & Vietnam.
  • Product Description
    Spine Referencing Instrumentation, Spinous Process Clamp, Tall || When used with a Medtronic StealthStation Navigation System, the Spine Referencing fixation devices are intended to provide rigid attachment between patient and patient reference frame for the duration of the surgery. The devices are intended to be reusable. The spine referencing clamps provide bony fixation through two styles of clamps; a single spinous process clamp and a double spinous process clamp.
  • Manufacturer


  • Manufacturer Address
    Medtronic Navigation, Inc., 826 Coal Creek Cir, Louisville CO 80027-9710
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source