Events

Recall of Device Recall INFUSE(R) Bone Graft

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
    65297
  • Event Risk Class
    Class 2
  • Event Number
    Z-1589-2013
  • Event Initiated Date
    2013-05-28
  • Event Date Posted
    2013-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-05-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118497
  • 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
    Filler, recombinant human bone morphogenetic protein, collagen scaffold with metal prosthesis, osteo - Product Code NEK
  • Reason
    Kits contain a collagen sponge recalled by integra due to possible elevated endotoxin levels resulting from a process deviation.
  • Action
    Medtronic on behalf of Integra LifeSciences Corporation sent an Urgent Voluntary Removal (Recall) letter on May 24, 2013, directly to all Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included. Foreign consignees were notified by email on May 28, 2013. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the product and discontinue use. The letter should be forwarded to surgeons or attending physicians who have used the affected products. Customers were instructed to use the attached questionnaire to account for product in their possession, document which physicians they notified and report any patient injuries that may have occurred related to the use of the affected product by calling the phone number in the questionnaire. Customers were asked to return the questionnaire using the enclosed self-addressed stamped envelope, via their Medtronic Sales Representative or via fax to 763-367-8134 For questions regarding this recall 901-399-3182. Customers were instructed to contact their Medtronic Sales Representative to coordinate the return and replenishment of affected product . Customers with questions should call 800-876-3133, ext 3197.

Device

Device Recall INFUSE(R) Bone Graft
  • Model / Serial
    Lots: M111057AAP, M111064AAD, M111064AAC, M111063AAJ, M111064AAK, M111064AAL, M111064AAV, M111064AAM, M111064AAW, M111064AAG, M111057AAM, M111063AAD, M111064AAQ, M111064AAO, M111064AAP, M111063AAP, M111064AAB, M111063AAC, M111064AAY, M111057AAD, M111057AAE
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: USA (nationwide including Puerto Rico) and Internationally to Australia, Brazil, Canada, Chile, Hong Kong, India, Mexico, Netherlands, , New South Wales, Panama, and Paraguay.
  • Product Description
    INFUSE(R) Bone Graft, SMALL KIT, REF 7510200, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 || orthopaedic
  • 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