Events

Recall of Medtronic TSRH 3DX Splined Connector

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK.

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
    50185
  • Event Risk Class
    Class 2
  • Event Number
    Z-1015-2009
  • Event Initiated Date
    2008-10-31
  • Event Date Posted
    2009-03-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74915
  • 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 MNI
  • Reason
    The thickness of the connector may be under specification, which could cause the implant to break during surgery or after implantation.
  • Action
    Hospital risk managers and implanting physicians were notified separately by letters dated 1/9/09. The letters advised of the recall, reported that a firm representative would visit the facility to pick up the recalled products. Physicians were instructed to closely monitor their patients during postoperative visits, to notify any other physician who may be monitoring the patient in lieu of the implanting physician, and to advise their patients to contact them immediately if they have any sudden and significant symptoms (increased discomfort, sudden change in their clinical symptoms, or new symptoms such as leg pain, back pain or irritation of local tissue). Customers were also instructed to complete and return the attached questionnaire to Medtronic SOFAMOR DANEK via mail (enclosed self-addressed stamped envelope) or fax at 901-399-2047. Direct questions to your Medtronic SOFAMOR DANEK Sales Representative or the firm's Global Quality Department at 800-876-3133, extension 6333.

Device

Medtronic TSRH 3DX Splined Connector
  • Model / Serial
    All lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including states of Arizona, Connecticut, Georgia, Indiana, Minnesota, New Jersey, New York, South Carolina, Texas and Washington.
  • Product Description
    Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512. || The device is intended for orthosis, spinal pedicle fixation for degenerative disc disease. The product is used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients; posterior non-cervical, non-pedicle screw fixation or for anterior use for certain conditions.
  • Manufacturer
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK

Manufacturer

Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
  • Manufacturer Address
    Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK, 2500 Silveus Crossing, Warsaw IN 46582-8598
  • Source
    USFDA