BEUDAMED
    FDA Recall Terminated

    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.

    Recall: Z-1200-06 · Initiated March 29, 2006

    Recall

    Recall Number
    Z-1200-06
    Event Number
    35132
    Firm
    Ossur North America Inc
    FEI Number
    1000519909
    Product Code
    ISY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 29, 2006
    Posted
    July 4, 2006
    Terminated
    August 8, 2008
    Address
    27412 Aliso Viejo Pkwy, Aliso Viejo, CA, 92656-3371

    Description

    Ossur Total Knee 2100, Model Number TK 2100, external prosthetic knee.

    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.

    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.

    Quantity

    413