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U.S. Department of Health and Human Services

Class 2 Device Recall Quicklock Tracker

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  Class 2 Device Recall Quicklock Tracker see related information
Date Initiated by Firm April 27, 2006
Date Posted September 23, 2008
Recall Status1 Terminated 3 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/
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
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 2
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.