Ossur Total Knee 2000, Model Number TK 2000, external prosthetic knee.

FDA device recall Z-1199-06 · posted 2006-07-04 · Terminated

Recall details

Recalling firm

Ossur North America Inc

Reason for recall

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 taken

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.

Root cause

Other

Status

Terminated

Product code

ISY

Quantity affected

1906

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,

Date initiated

2006-03-29

Date posted

2006-07-04

Date terminated

2008-08-08

Location

Aliso Viejo, CA