Events

Recall of Implant Hollow Reamer, 14 mm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Sofamor Danek Instrument Manufacturing.

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
    36123
  • Event Risk Class
    Class 2
  • Event Number
    Z-0050-2007
  • Event Initiated Date
    2006-08-01
  • Event Date Posted
    2006-10-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48045
  • 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
    bone reamer - Product Code HTO
  • Reason
    Bone reamer may not have a cutting surface on the tip.
  • Action
    The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.

Device

Implant Hollow Reamer, 14 mm
  • Model / Serial
    Lot Nos.: CN04J012, CN06A003
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
  • Manufacturer
    Medtronic Sofamor Danek Instrument Manufacturing

Manufacturer

Medtronic Sofamor Danek Instrument Manufacturing
  • Manufacturer Address
    Medtronic Sofamor Danek Instrument Manufacturing, 2975 Brother Blvd, Bartlett TN 38133-3957
  • Source
    USFDA