Events

Recall of Device Recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100

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
    67267
  • Event Risk Class
    Class 2
  • Event Number
    Z-0977-2014
  • Event Initiated Date
    2014-01-06
  • Event Date Posted
    2014-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125127
  • 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, bone void, osteoinduction (w/o human growth factor) - Product Code MBP
  • Reason
    Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
  • Action
    The firm, Medtronic, sent an "URGENT-V voluntary Market Removal (Recall)" communication letter and questionnaire packet (via FedEx) dated January 3, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to remove the product from normal storage locations; Do not use the product; and as applicable, contact your Medtronic Sales Representative to coordinate the return and replenishment of affected product or call our Global Quality Department at 800-876-3133 ext 3197. In addition, the customers were instructed to disseminate this information to additional personnel within your facility as appropriate. A Medtronic Sales Representative will contact you to facilitate the return of any impacted Set Screw Retaining Drivers you may have in your possession. If you need assistance or if you have any related questions or concerns, please do not hesitate to contact your Medtronic Sales Representative or our Global Quality Department at 800-876-3133 extension 3197.

Device

Device Recall Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100
  • Model / Serial
    A16707-098, A16707-099, A16707-100, A16707-101, A16707-102, A16707-103, A16707-104, A16707-105, A16707-106, A16707-107, A16707-108, A16707-109, A16707-110, A16707-111, A16707-112, A16707-113, A16707-114, A16707-115, A16707-116, A16707-117, A16707-118, A16707-119, A16707-120, A16707-121, A16707-122, A16707-123, A16707-124, A16707-125, A16707-142, and A16707-147
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution in the states of: MO, FL, MN, OH, MI, TX, and NJ.
  • Product Description
    Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc., 1800 Pyramid Place, Memphis, TN 38132 || Orthopaedic - filler, bone void
  • 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