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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 14, 2004
Date Posted October 19, 2004
Recall Status1 Terminated 3 on October 18, 2004
Recall Number Z-0020-05
Recall Event ID 29675
510(K)Number K022365  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Stryker Navigation System - Hip Module Patient Tracker, green; Model 6007-005-000.
Code Information Serial numbers PG04-0001 through PG04-0017.
Recalling Firm/
Manufacturer		 Stryker Instruments, Instruments Div.
4100 E. Milham
Kalamazoo MI 49001
For Additional Information Contact Becky Ditty
269-323-770 Ext. 3434
Manufacturer Reason
for Recall		 The tracker is not locking adequately to the anchoring pin, resulting in unacceptable movement, which will affected the patient tracker system.
FDA Determined
Cause 2		 Other
Action Sales force was notified these pre-launch devices are not to be used for surgical use via e-mail and telephone calls on 7/14/04.
Distribution United States.
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 = STRYKER INSTRUMENTS
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