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U.S. Department of Health and Human Services

Class 2 Device Recall da Vinci S Surgical System 8 mm Long instrument cannula

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 Class 2 Device Recall da Vinci S Surgical System 8 mm Long instrument cannulasee related information
Date Initiated by FirmMarch 09, 2007
Date PostedJanuary 31, 2008
Recall Status1 Terminated 3 on April 19, 2011
Recall NumberZ-0658-2008
Recall Event ID 38315
510(K)NumberK050369 
Product Classification Cannula - Product Code NAY
Productda Vinci S Surgical System 8 mm Long instrument cannula, Part #:420004-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086,
Code Information Part #420004-01, Lot Numbers: SA054702, SA060504, SA062801, and SA062104
Recalling Firm/
Manufacturer		 Intuitive Surgical, Inc.
950 Kifer Rd
Sunnyvale CA 94086
For Additional Information Contact
408-523-2100
Manufacturer Reason
for Recall		Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm issued an Important Device Recall Notification on 3/9/2007, announcing the recall and exchange program for device replacement. A toll free number of 1-800-876-1310 was given in the recall notice for questions.
Quantity in Commerce206 units
DistributionWorldwide: 92 hospitals nationwide and abroad, as well as 6 distributors abroad, USA including the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OR, PA, SD, TN, TX, VA, WA, WI, and WV and countries of Belgium, China, France, Germany, India, Italy, Japan, Mexico, The Netherlands, Spain and Sweden.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NAY
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