Recall Z-1228-2010
Ortho Development Corporation · initiated March 19, 2009
Product
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) Revision procedures where other treatments or devices have failed.
Codes / lots: 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.
Reason for recall
A component of knee prosthesis was assembled incorrectly.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1228-2010
- Initiated
- March 19, 2009
- Posted by FDA
- April 5, 2010
- Terminated
- June 30, 2010
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 422 units
- Distribution
- United States (AZ, FL, OR, TX and UT) and Japan.
- Recalling firm
- Ortho Development Corporation, Draper, UT
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1229-2010 | 5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The…A component of knee prosthesis was assembled incorrectly. | 03/19/2009Terminated |