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U.S. Department of Health and Human Services

Class 2 Device Recall DriLok Disposable Cannula

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  Class 2 Device Recall DriLok Disposable Cannula see related information
Date Initiated by Firm December 01, 2008
Date Posted January 16, 2009
Recall Status1 Terminated 3 on January 10, 2011
Recall Number Z-0868-2009
Recall Event ID 50525
510(K)Number K944210  
Product Classification Arthroscope and accessories (obturator and cannula) - Product Code HRX
Product Dri-Lok Disposable Cannula, Part numbers 3910-075-500, 3910-075-501, 3910-075-502, 3910-075-650, 3910-075-651, 3910-075-652, 3910-075-800, 3910-075-801, 3910-075-802, 3910-090-500, 3910-090-502, 3910-090-650, 3910-090-652, 3910-090-800, and 3910-090-802.

The obturator is used to create an opening into the patient's joint and is removed after the cannula is inserted. The cannula then allows instruments and scopes access to the joint while maintaining a seal against the loss of saline fluid used to keep the joint clean. The seal is formed by two elastomeric valves. The first controls loss of water when there is no instrument or scope therein, while the second provides a seal when the cannula is in use. The valves operate automatically.

Manufactured by Stryker Endoscopy Puerto Rico
Code Information Lot numbers 08135AG2 through 08294AG2.
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		 Leak: Leak-resistant barrier may not properly seal and leak when an instrument is inserted, and keep leaking after instrument is removed.
FDA Determined
Cause 2		 Component change control
Action Recall initiated 12/01/2008, Sales representatives were notified via telephone and e-mail. Product advisories entitled ""Urgent: Device Removal" and dated December 1, 2008, were sent to all consignees. All unused product is to be returned to the firm. For further information, please contact Stryker Endoscopy by telephone at 408-754-2124.
Quantity in Commerce 4,194 boxes (24,750 units)
Distribution Worldwide Distribution --- including USA and countries of Australia, Brazil, Canada, Chile, China, France, Germany, Greece, India, Italy, New Zealand, Poland, Portugal, Sweden, Spain, Singapore, Switzerland, and UK.
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 = HRX and Original Applicant = Stryker Endoscopy
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