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) Revision procedures where other treatments or devices have failed.
Recall
- Recall Number
- Z-1229-2010
- Event Number
- 51926
- Firm
- Ortho Development Corporation
- FEI Number
- 3017298928
- Product Code
- JWH
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 19, 2009
- Posted
- April 5, 2010
- Terminated
- June 30, 2010
- Address
- 12187 South Business Park Dr, Draper, UT, 84020
Description
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) Revision procedures where other treatments or devices have failed.
A component of knee prosthesis was assembled incorrectly.
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.
United States (AZ, FL, OR, TX and UT) and Japan.
368 units