Date Initiated by Firm | September 08, 2006 |
Date Posted | October 03, 2006 |
Recall Status1 |
Terminated 3 on December 04, 2007 |
Recall Number | Z-0008-2007 |
Recall Event ID |
36214 |
510(K)Number | K004027 K993239 |
Product Classification |
Navigation System - Product Code HAW
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Product | Stryker Navigation System, Navigation Laptop System with Dell laptop computer model D800, Stryker # 6000-200-000. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Stryker Instruments Div. of Stryker Corporation 4100 E Milham Ave Portage MI 49002-9704
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For Additional Information Contact | Jennifer Hoffman 800-800-4236 Ext. 4056 |
Manufacturer Reason for Recall | A component of the device is a Dell laptop computer, which contains batteries that are under recall because they can overheat and cause a fire. |
FDA Determined Cause 2 | Other |
Action | A recall letter dated 9/8/06 was sent to each customer instructing them to remove the battery from their Dell laptop computer model D800, to check the batteries to determine whether they are affected by the recall, and to only use the computer on AC power until they have requested and received replacement batteries. |
Quantity in Commerce | 218 units for Recalls Z-0005/0008-2007 |
Distribution | Worldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = HAW 510(K)s with Product Code = HAW
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