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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci 5 mm Flared Instrument Cannulae

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  Class 2 Device Recall da Vinci 5 mm Flared Instrument Cannulae see related information
Date Initiated by Firm May 06, 2013
Date Posted June 05, 2013
Recall Status1 Terminated 3 on April 15, 2014
Recall Number Z-1464-2013
Recall Event ID 65168
Product Classification System,surgical,computer controlled instrument - Product Code NAY
Product da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si Surgical Systems.

Used to establish a port of entry for Intuitive Surgical EndoWrist instruments
Code Information Model number 420262
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
1266 Kifer Rd Bldg 100
Sunnyvale CA 94086-5304
For Additional Information Contact Richard Reeves
408-523-2244
Manufacturer Reason
for Recall		 Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection process for the 5 mm Cannula (PN 420011) and 5 mm Flared Cannula (PN 420262).
FDA Determined
Cause 2		 Use error
Action Intuitive Surgical sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 14, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact Customer Service at 800-876-1310 for questions regarding this notice.
Quantity in Commerce 2101 consignees
Distribution Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, 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.
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