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U.S. Department of Health and Human Services

Class 2 Device Recall Component of Ortho Development Balanced Knee Modular Tibial System.

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  Class 2 Device Recall Component of Ortho Development Balanced Knee Modular Tibial System. see related information
Date Initiated by Firm March 19, 2009
Date Posted April 05, 2010
Recall Status1 Terminated 3 on June 30, 2010
Recall Number Z-1229-2010
Recall Event ID 51926
510(K)Number K031201  
Product Classification Tibial Augment 5mm Block - Product Code JWH
Product 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-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: 567-5101; 567-5102; 567-5103; 567-5104; 567-5105; 567-5106; 567-5201; 567-5202; 567-5203; 567-5204; 567-5205 and 567-5206.
Recalling Firm/
Manufacturer		 Ortho Development Corporation
12187 South Business Park Dr
Draper UT 84020
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 368 units
Distribution United States (AZ, FL, OR, TX and UT) and Japan.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = ORTHO DEVELOPMENT CORP.
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