Recall Z-1229-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
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-tra
| Date | Apr 5, 2010 (initiated Mar 19, 2009) |
| Status | Terminated |
| Reason | A component of knee prosthesis was assembled incorrectly. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 368 units |
| Distribution | United States (AZ, FL, OR, TX and UT) and Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM Ortho Development Corp., Jul 15, 2003 |