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Class 2 Device Recall Stryker Navigation System pin |
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Date Initiated by Firm |
June 05, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on December 01, 2009 |
Recall Number |
Z-2289-2008 |
Recall Event ID |
48710 |
510(K)Number |
K022365 K022579
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Product Classification |
Pin - Product Code HAW
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Product |
Stryker Navigation Pin for use with the Stryker Navigation System, 3 mm x 150 mm, Stryker, Kalamazoo, MI; Part 6007-003-150. 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
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For Additional Information Contact |
269-323-7700 Ext. 3808
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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.
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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
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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 and Original Applicant = STRYKER INSTRUMENTS 510(K)s with Product Code = HAW and Original Applicant = STRYKER LEIBINGER
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