Events

Recall of Device Recall adjustable drill stop

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek USA 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
    61453
  • Event Risk Class
    Class 2
  • Event Number
    Z-1443-2012
  • Event Initiated Date
    2012-03-13
  • Event Date Posted
    2012-04-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108139
  • 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 manual surgical instrument - Product Code LXH
  • Reason
    Drill stops may be bypassed when the device is used with powered drilling instruments.
  • Action
    Medtronic notified their US Sales force on March 5, 2012, of the upcoming field action. The written "Voluntary Recall" communications were disseminated March 13 and March 14 to the US consignees. The letter identified the affected products, problem and actions to be taken. Customers are instructed to 1) disseminate this information to personnel within their facility as appropriate; 2) review work area, district sales office, and sample inventory for affected product; 3) complete the attached Risk Manager Questionnaire and return any recalled product; and 4) Sign and acknowledge the attached Sales Rep Questionnaire indicating receipt of this letter. For questions or concerns, contact your Medtronic Sales Representative or Global Quality Department at 800-876-3133, extension 3197.

Device

Device Recall adjustable drill stop
  • Model / Serial
    Lot Numbers: EM09F012, EM09F013, EM09F014, EM09F015, EM09F016, EM09F017, EM10A010, EM10A0101, EM11G042, IM83002, IT03G009, IT03H011, IT03J035, IT03M011, IT04A007, IT04C015, IT04D025, IT04F005, IT04G001, IT06A014, IT06A0141, IT06L042, IT07C028, IT09891, IT09892, IT09953, IT10050, IT10051, IT10308, IT10808, IT10906, IT10907, IT11222, IT11698, IT11874, SK10341, SK10777
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Barbados, Brazil, Netherlands, Hong Kong, Japan, Korea, Columbia, Chile, Canada, India, Jamaica, Switzerland, Costa Rica, Ecuador, and Mexico.
  • Product Description
    PREMIER(R) Anterior Cervical Plate System Adjustable Drill Stop, REF 6905712, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 || Product Usage: || Manual orthopedic adjustable drill stop
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Manufacturer Address
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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
    USFDA