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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Navigation System

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 Class 2 Device Recall Stryker Navigation Systemsee related information
Date Initiated by FirmSeptember 08, 2006
Date PostedOctober 03, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall NumberZ-0007-2007
Recall Event ID 36214
510(K)NumberK004027 K993239 
Product Classification Navigation System - Product Code HAW
ProductStryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.
Code Information All units.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information ContactJennifer 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
ActionA 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 Commerce218 units for Recalls Z-0005/0008-2007
DistributionWorldwide- USA and countries of Australia, Canada, France, Germany, Hong Kong, Italy, Japan, Mexico, New Zealand, South Korea, Switzerland and United Kingdom.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HAW
510(K)s with Product Code = HAW
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