10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) R
Hazard
A component of knee prosthesis was assembled incorrectly.
What You Should Do
Remedy
E-mail was sent to all agents and distributors on March 19, 2009 with illustrations and instructions on how to detect the upside down assembly and how to correct the problem if detected during surgery. Direct questions to the Ortho Development Corporation by calling 1-801-619-3444.
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Products
10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System.
The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from
- Brand
- Ortho Development Corporation
- UPC
- Serial numbers: 567-1101; 567-1102; 567-1103; 567-1104; 567-1105; 567-1106; 567-1201; 567-1202; 567-1203; 567-1204; 567-1205 and 567-1206.
Units Affected
422 units