Class 2 Device Recall STRYKER NAVIGATION SYSTEM iNtellect Cranial Planning Software

• Date Initiated by Firm: November 10, 2010
• Date Posted: February 25, 2011
• Recall Status: Terminated on June 01, 2011
• Recall Number: Z-1408-2011
• Recall Event ID: 57487
• 510(K)Number: K062640
• Product Classification: Neurological Stereotaxic Instrument - Product Code HAW
• Product: Stryker Navigation System - iNtellect Cranial Navigation/Planning Software, Part number 6000-652-000. It is part of the product series of the Stryker Navigation System. The system comprises software for pre-operative surgical planning and supports computer assisted surgery based on a wireless optical tracking localization device for the use in navigated cranial surgery. It includes automatic multi-modality correlation. The system provides an easy-to-use work flow concept for image importation, FESS, Craniotomy, Biopsy, etc. Additional, automatic segmentation of brain surface, tumor, vessels, etc. are supported.
• Code Information: Verisions 1.0 and 1.1; all batches: J3500F3002; J4900F3002; JAQ00F3002; K2A00F3002; K7W00F3003; K8T00F3003; KB500F3003; KBT00F3003; L1E00F3003; L1S00F3003; L4700F3003; L6U00F3001; and L7V00F3003
• Recalling Firm/ Manufacturer: Stryker Instruments Division of Stryker Corporation; 4100 East Milham Ave.; Kalamazoo MI 49001
• For Additional Information Contact: Stryker Field Action Team ; 800-200-4263 Ext. 3808
• Manufacturer Reason for Recall: When users imports more than one image set and changes the viewing direction for both images, the orientation of every other image series might be stored incorrectly, as a mirror image. This may lead to insufficient or inaccurate correlation results or incorrectly shown orientation of every second image series during navigation.
• FDA Determined Cause: Software design
• Action: Urgent: Medical Device Recall Notification letters were sent on 12/3/2010, and software upgrades were to be performed in the field by the end of 2010. Specific Customer Instructions: 1) Locate the units listed in the notification. 2) Distribute this notification to all departments affected. 3) Return the enclosed business reply form to confirm receipt of this notification and identify how many affected units are currently in your inventory. 4) Once the new software is available, Stryker will dispatch a service tech in order to update the software. Note: Software upgrades for all applications will be available by the end of the year. The upgrades will be scheduled as we receive your business reply form. Note: If you currently have a Time License or Pay Per Use card, a new one will be issued to you at the time of the update. 5) If you have loaned or sold any of the units listed in this notification, please, forward a copy of this notice to the new users and advise Stryker of the new users name and their new location. 6) If you have disposed of any of the affected units and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. Questions regarding this recall should be directed to Stryker Field Action Team at 800-800-4236, ext 3808, 3584, or 4354 between the hours of 8 a.m. - 5 p.m. Monday - Friday.
• Quantity in Commerce: 1,155 total
• Distribution: Worldwide Distribution -- USA, Canada, Mexico, Australia, Argentina, Brazil, United Kingdom, Japan, Poland, S. Korea, Hong Kong, Taiwan, India, and New Zealand.
• 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