Class 2 Device Recall Quicklock Tracker

• Date Initiated by Firm: April 27, 2006
• Date Posted: September 23, 2008
• Recall Status: Terminated on March 11, 2009
• Recall Number: Z-2444-2008
• Recall Event ID: 49121
• 510(K)Number: K041369
• Product Classification: Surgical instrument - Product Code HAW
• Product: Quicklock Tracker, Size 2, Manufactured by Orthosoft, Montreal, Canada; Distributed by Smith & Nephew, Inc., Memphis, TN; ref: 111.100. Device is a surgical instrument.
• Code Information: Lots: PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and PC050034-1.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: The three-point array may break during use, resulting in surgical delay and an increased risk of infection.
• FDA Determined Cause: Device Design
• Action: Consignee was notified by phone and email on or about 4/27/06. Contact Zimmer Inc. at 1-574-267-6131 for assistance.
• Quantity in Commerce: 239
• Distribution: Nationwide
• 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 = HAW and Original Applicant = ORTHOSOFT, INC.