Date Initiated by Firm | March 19, 2009 |
Date Posted | April 05, 2010 |
Recall Status1 |
Terminated 3 on June 30, 2010 |
Recall Number | Z-1228-2010 |
Recall Event ID |
51926 |
510(K)Number | K031201 |
Product Classification |
Tibial Augment 10 degree Wedge - Product Code JWH
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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. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Ortho Development Corporation 12187 South Business Park Dr Draper UT 84020
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For Additional Information Contact | 801-619-3450 |
Manufacturer Reason for Recall | A component of knee prosthesis was assembled incorrectly. |
FDA Determined Cause 2 | 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 in Commerce | 422 units |
Distribution | United States (AZ, FL, OR, TX and UT) and Japan. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = JWH
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