Ortho Development Corporation 5mm Tibial Augment Block, 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) Revisio Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
5mm Tibial Augment Block, 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) Revisio
Brand
Ortho Development Corporation
Lot Codes / Batch Numbers
Serial Numbers: 567-5101, 567-5102, 567-5103, 567-5104, 567-5105, 567-5106, 567-5201, 567-5202, 567-5203, 567-5204, 567-5205 and 567-5206.
Products Sold
Serial Numbers: 567-5101; 567-5102; 567-5103; 567-5104; 567-5105; 567-5106; 567-5201; 567-5202; 567-5203; 567-5204; 567-5205 and 567-5206.
Ortho Development Corporation is recalling 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a due to A component of knee prosthesis was assembled incorrectly.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A component of knee prosthesis was assembled incorrectly.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026