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.
This recall has been terminated (originally issued April 5, 2010).
- Company
- Ortho Development Corporation
- Recall Initiated
- March 19, 2009
- Posted
- April 5, 2010
- Terminated
- June 30, 2010
- Recall Number
- Z-1228-2010
- Quantity
- 422 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
A component of knee prosthesis was assembled incorrectly.
Distribution
United States (AZ, FL, OR, TX and UT) and Japan.
Lot / Code Info
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.
Root 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.
More recalls by Ortho Development Corporation
PS Tibial Insert, REF 163-1XXX
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