Ossur Total Knee, Model Number: 2100 The Total Knee 2100 is an external prosthetic knee joint. It is a polycentric knee

FDA device recall Z-1822-2011 · posted 2011-03-25 · Terminated

Recall details

Recalling firm

Ossur Engineering, Inc

Reason for recall

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 taken

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.

Root cause

Process design

Status

Terminated

Product code

ISY

Quantity affected

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,

Date initiated

2011-02-11

Date posted

2011-03-25

Date terminated

2012-02-29

Location

Albion, MI