Events

Recall of Ossur Total Knee

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur.

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
    38115
  • Event Risk Class
    Class 2
  • Event Number
    Z-1076-2007
  • Event Initiated Date
    2007-04-02
  • Event Date Posted
    2007-07-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=52982
  • 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
    external knee prosthesis - Product Code ISY
  • Reason
    Some units of the total knee model 2100 produced from august 1, 2006 through october 4, 2006 may contain a faulty linkage component.
  • Action
    On 4/2/07 a letter was mailed to all affected customers via certified mail, return receipt requested. All mailing will be followed by telephone calls from an Ossur Customer Service Representative. Customers were notified that Ossur will replace the affected knees with units carrying a two-year warranty from the date of replacement. Ossur will undertake a sub-recall by notifying the one affected distributor by letter on 4/2/07. Ossur will follow up with this distributor by telephone and request a list of consignees that the distributor sold the product to so that Ossur can directly contact each of those consignees. Upon receipt of this list, Ossur will then communicate the recall information directly to these consignees.

Device

Ossur Total Knee
  • Model / Serial
    US affected Serial Numbers (1) New units: 9056, 9062, 9063, 9088, 9089, 9090, 9092, 9094, 9095, 9096, 9097, 9099, 9100, 9101, 9102, 9103, 9104, 9105, 9106, 9107, 9108, 9109, 9110, 9111, 9112, 9113, 9114, 9115, 9116, 9117, 9118, 9127, 9129, 9130, 9159, 9160, 9162, 9163, 9166 and 9169.   (2) Repaired units: 5138, 5141, 6624 and 9098.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Ossur Total Knee Model Number 2100, external knee prosthesis.
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Manufacturer Address
    Ossur, Grjothals 5, Reykjavik Ireland
  • Source
    USFDA