Events

Recall of Device Recall Ossur Total Knee

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur North America 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
    35132
  • Event Risk Class
    Class 2
  • Event Number
    Z-1200-06
  • Event Initiated Date
    2006-03-29
  • Event Date Posted
    2006-07-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45391
  • 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
    Joint, Knee, External Limb Component - Product Code ISY
  • Reason
    The company's initiation of the recall is based on a finding that some units of the total knee device may contain faulty pins based in the axis of the knee. small cracks propagate through the pin cross section until the pin breaks, severely compromising the knee function.
  • Action
    On 3/29/06 a press release was posted on OandP.com, an industry specific web site. An announcement listing involved serial numbers and contact phone numbers was also posted on the company''s web site, ossur.com. A two stage mailing has been constructed. The first letter sent to all customers March 30, 2006, describes the problem and models affected. The second letter, March 31, 2006, is customer specific and lists all of the involved serial numbers by model which were purchased by that customer. Telephone calls will be placed to customers who do not respond to the mailings.

Device

Device Recall Ossur Total Knee
  • Model / Serial
    Serial numbers: 6918 ¿ 7569
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Distribution worldwide in Austria, Canada, Columbia, Hong Kong, Japan, Korea, Kuwait, Malaysia, Mexico, Taiwan, & New Zealand. Involved states are: AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, AND WY.
  • Product Description
    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.
  • Manufacturer
    Ossur North America Inc

Manufacturer

Ossur North America Inc
  • Manufacturer Address
    Ossur North America Inc, 27412 Aliso Viejo Pkwy, Aliso Viejo CA 92656-3371
  • Source
    USFDA