da Vinci S Surgical System 8 mm instrument cannula, Part #: 420002-01, Intuitive Surgical, Inc., Sunnvale, Ca. 94086
FDA Recall Z-0657-2008 · Posted 2008-01-31
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Recalling FirmIntuitive Surgical, Inc.
Recall StatusTerminated
Product CodeNAY
Date Initiated2007-03-09
Date Terminated2011-04-19
Product Quantity679 units
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.
Firm Action
The 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide: 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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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