Ossur Total Knee Junior, Model Number TK 1100, External Prosthetic knee.
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Ossur North America Inc
- UPC
- Serial numbers: 5787 ¿ 6207 including the following repaired units outside the stated range. 5339, 5471, 5478, 5670.
Units Affected
285