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 Engineering, 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
    58002
  • Event Risk Class
    Class 2
  • Event Number
    Z-1822-2011
  • Event Initiated Date
    2011-02-11
  • Event Date Posted
    2011-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97954
  • 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 - Product Code ISY
  • Reason
    The recall was initiated based on a finding by ossur that some units of the total knee 2100 produced from october 19th, 2010 until january 21st 2011, contained back links that may compromise knee function prematurely.
  • Action
    Ossur initiated a Safety Notice (Voluntary Product Recall) letter on February 11, 2011, via US Postal Service Registered Mail. The recall letter informed the affected customers of the reason for the recall and the product affected. Ossur requested their distributor and providers take the following action: (1) Please identify the users of each of the Total Knee 2100 model devices listed above; (2) Also, please check your inventory and isolate any recalled devices you have on hand but have not fitted on users. Customers were also informed that a representative from Ossur customer service will be contacting them to coordinate replacement of the affected devices. The letters were followed by phone calls placed by a trained Ossur Customer Service Representative to each customer after US distributors provided Ossur with customer contact information. For questions regarding this recall call 517-629-8890.

Device

Device Recall Ossur Total knee
  • Model / Serial
    Serial Numbers (new units):13241, 13243, 13245, 13246, 13247, 13248, 13251, 13252, 13253, 13254, 13255, 13256, 13259, 13260, 13261, 13262, 13263, 13264, 13265, 13266, 13267, 13268, 13269, 13270, 13271, 13272, 13282, 13284, 13285, 13286, 13287, 13289, 13290, 13293, 13296, 13297, 13298, 13300, 13301, 13302, 13304, 13306, 13307, 13308, 13309, 13310, 13311, 13312, 13313, 13314, 13315, 13317, 13318, 13319, 13320, 13321, 13322, 13323, 13324, 13325, 13326, 13327, 13329, 13330, 13331, 13332, 13333, 13334, 13335, 13336, 13337, 13338, 13339, 13340, 13341, 13342, 13344, 13345, 13346, 13347, 13348, 13349, 13350, 13351, 13352, 13353, 13354, 13358, 13360, 13363, 13364, 13365, 13368, 13369, 13370, 13371, 13372, 13373, 13374, 13375, 13376, 13377, 13378, 13379, 13380, 13381, 13384, 13385, 13386, 13387, 13393, 13394, 13395, 13397, 13399, 13400, 13401, 13407, 13409, 13410, 13411, 13412, 13413, 13414, 13415, 13416, 13417, 13418, 13420, 13431  Repairs units: 9611, 10325, 10616, 11615, 11747, 11795, 12091, 12092, 12097, 12098, 12101, 12104
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, FL, LA, MD, MI, MO, NJ, NY, OH, TN, VA,, and WA and the countries of Australia, Canada, Czech Republic, Germany, France, United Kingdom, Ireland, Italy, Japan, The Netherlands, Russian Federation, Sweden and Turkey.
  • Product Description
    Ossur Total Knee, Model Number: 2100 || The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee designed for multi-speed ambulators, higher impact levels and heavier loads.
  • Manufacturer
    Ossur Engineering, Inc

Manufacturer

Ossur Engineering, Inc
  • Manufacturer Address
    Ossur Engineering, Inc, 910 Burstein Dr, Albion MI 49224-4011
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA