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U.S. Department of Health and Human Services

Class 1 Device Recall Stryker Instruments Navigation System II PC SPC1 Assembly

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  Class 1 Device Recall Stryker Instruments Navigation System II PC SPC1 Assembly see related information
Date Initiated by Firm October 26, 2009
Date Posted November 20, 2009
Recall Status1 Terminated 3 on December 31, 2009
Recall Number Z-0123-2010
Recall Event ID 53614
510(K)Number K993239  
Product Classification Neurological Stereotaxic Instrument - Product Code HAW
Product Stryker Instruments Navigation System II PC SPC-1 Assembly, Stryker Navigation, Kalamazoo, MI; REF 7700-101-201.

The Stryker Navigation System II is a computer-aided surgery platform, supporting surgeons to perform surgical interventions.
Code Information Serial number K7P00F6000.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information Contact
800-800-4236 Ext. 4354
Manufacturer Reason
for Recall		 Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
FDA Determined
Cause 2		 Software design
Action The firm issued a press release on 11/4/09. Consignees were notified by an Urgent: Medical Device Recall Notification letter dated 10/23/09, which advised of the affected products, the reason for the recall, the recall plan, and the actions to be taken. Customers were to immediately review this notification and distribute to all departments affected. Also, customers were to immediately quarantine any affected product and label as recalled product; complete and sign the enclosed Business Reply Form and fax a copy to 866-521-2762. Upon receipt of the form, a Stryker Navigation Field Service Rep would contact them to schedule the repair of their equipment. All U.S. units were corrected by 10/30/09.
Quantity in Commerce 2 replacement systems
Distribution Worldwide Distribution -- USA, including states of Florida, Kansas, Kentucky, Massachusetts, Michigan, New Jersey, Pennsylvania, South Carolina, Texas, and Washington and countries of Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom.
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 CORP.
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