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U.S. Department of Health and Human Services

Class 2 Device Recall End Cutter Shaver Blade FSeries, 4.0 mm

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  Class 2 Device Recall End Cutter Shaver Blade FSeries, 4.0 mm see related information
Date Initiated by Firm November 12, 2009
Date Posted December 28, 2010
Recall Status1 Terminated 3 on January 03, 2011
Recall Number Z-0825-2011
Recall Event ID 54147
510(K)Number K9413333  
Product Classification Arthroscope - Product Code HRX
Product Stryker brand End Cutter Shaver Blade F-Series, 4.0 mm; Model Number -375-747-000, manufactured by Stryker Puerto Rico
Code Information Lot Number: 09203CE2
Recalling Firm/
Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact Nila Patel
Manufacturer Reason
for Recall
Potential breakage of the internal shaft of the End Cutter Shaver Blade; F-Series, 4.0mm. if breakage occurs, the device becomes non-functional and the defect could be observed through the camera/console system.
FDA Determined
Cause 2
Device Design
Action Stryker issued Urgent Product Recall letters dated November 12, 2009 to all its direct consignees, informing them of the affected products and providing instructions on the recall. Customers were requested to return the product to Stryker. Stryker can be contacted concerning this recall at 408 754-2124.
Quantity in Commerce 295 units
Distribution Nationwide Distribution includes: Arizona, California, Colorado, Denver, Florida, Hawaii, Illinois, Kansas, Kentucky, Massachusetts, Michigan, New York, Ohio, and South Carolina.
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.