Recall Z-1822-2011 ยท ISY Joint, Knee, External Limb Component
Ossur Engineering, Inc
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.
| Date | Mar 25, 2011 (initiated Feb 11, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Process design |
| 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 |
| Quantity | 142 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.