Events

Recall of Medtronic Sofamor Danek Bone fragmentor

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
    36701
  • Event Risk Class
    Class 2
  • Event Number
    Z-0176-2007
  • Event Initiated Date
    2006-10-20
  • Event Date Posted
    2006-11-14
  • 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=49187
  • 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 Fragmentor - Product Code LYS
  • Reason
    Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.
  • Action
    The firm notified its consignees of the problem and the recall by letter delivered via overnight mail on 10/20/2006. The firm''s overseas distributors were also notified via electronic mail on 10/20/2006. The notices requested the discontinuation of use and stated that sales representatives would be retrieving the devices from them.

Device

Medtronic Sofamor Danek Bone fragmentor
  • Model / Serial
    Lot numbers: 36197, 36200, 36198, 36199, 36196, 40591, 54685, 70942, 70605, 74679, 18150, 20271, 7935
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA and countries of The Netherlands, Hong Kong, and Japan.
  • Product Description
    Medtronic Sofamor Danek Bone fragmentor Ref Number/Model # 9150111
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Manufacturer Address
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132-1719
  • Source
    USFDA