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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Navigation System pin

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  Class 2 Device Recall Stryker Navigation System pin see related information
Date Initiated by Firm June 05, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on December 01, 2009
Recall Number Z-2290-2008
Recall Event ID 48710
510(K)Number K022365  K022579  
Product Classification Pin - Product Code HAW
Product Stryker Navigation Pin for use with the Stryker Navigation System, 4 mm x 100 mm, Stryker, Kalamazoo, MI; Part 6007-004-100. Stryker Navigation Pin for use with the Stryker Navigation System is used for trauma and orthopedic applications, e.g. hip and knee modules.
Code Information All units distributed prior to 6/5/08.
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Portage MI 49002-9704
For Additional Information Contact
269-323-7700 Ext. 3808
Manufacturer Reason
for Recall		 Instructions have been updated to include new warnings regarding percutaneous pin placement during surgery in order to mitigate the risk of femur fractures.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Consignees were notified via letter dated 6/5/08 providing them with additional warnings and instructions for use for these products. Contact Stryker Customer Service at 1-800-800-4236, ext. 3808.
Quantity in Commerce 28,861 boxes of all products.
Distribution Nationwide, Austria, Australia, Brazil, Canada, China, Dubai, England, France, Germany, Hong Kong, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Singapore, South Africa, South Korea, Sweden, Switzerland and Taiwan.
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
510(K)s with Product Code = HAW and Original Applicant = STRYKER LEIBINGER
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