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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 System see related information
Date Initiated by Firm September 08, 2006
Date Posted October 03, 2006
Recall Status1 Terminated 3 on December 04, 2007
Recall Number Z-0005-2007
Recall Event ID 36214
510(K)Number K993239  K004027  
Product Classification Navigation system - Product Code HAW
Product Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Code Information All units.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
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
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.
510(K)s with Product Code = HAW and Original Applicant = STRYKER INSTRUMENTS
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