Class 2 Device Recall

• Date Initiated by Firm: July 14, 2004
• Date Posted: October 19, 2004
• Recall Status: Terminated on October 18, 2004
• Recall Number: Z-0021-05
• Recall Event ID: 29675
• 510(K)Number: K022365
• Product Classification: Neurological Stereotaxic Instrument - Product Code HAW
• Product: Stryker Navigation System - Hip Module Patient Tracker, blue; Model 6007-010-000.
• Code Information: Serial numbers PG04-0006 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: 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