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.
FDA Recall Z-1228-2010 · Posted 2010-04-05
Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-03-19
Date Terminated2010-06-30
Product Quantity422 units
Reason for Recall
A component of knee prosthesis was assembled incorrectly.
Firm 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.
Root Cause
Device Design
Distribution Pattern
United States (AZ, FL, OR, TX and UT) and Japan.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.