Events

Recall of Device Recall Rocker Reducer

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
    37066
  • Event Risk Class
    Class 2
  • Event Number
    Z-0411-2007
  • Event Initiated Date
    2006-12-18
  • Event Date Posted
    2007-02-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-07-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49842
  • 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
    spinal implant instrument - Product Code MNI
  • Reason
    Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use.
  • Action
    The firm sent out the recall letter via Federal Express to direct consignees on 12/18/2006. The letter explained the problem, requested discontinuation of use and stated that sales representatives would be coordinating the retrieval and replacement of the device.

Device

Device Recall Rocker Reducer
  • Model / Serial
    Lot numbers: MH05F006 and MH05J015
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.
  • Product Description
    Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA
  • 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