Class 3 Device Recall Balanced Knee System

• Date Initiated by Firm: September 15, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on December 11, 2003
• Recall Number: Z-0042-04
• Recall Event ID: 27300
• Product Classification: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
• Product: Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
• Code Information: Part # 252-0300, Lot # W007919.
• Recalling Firm/ Manufacturer: Ortho Development Corporation; 12187 Business Park Drive; Draper UT 84020
• For Additional Information Contact: Nadeem Ahmed; 801-553-9991
• Manufacturer Reason for Recall: The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
• FDA Determined Cause: Other
• Action: The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.
• Quantity in Commerce: 27
• Distribution: Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in 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.