FDAFDA · Food and drugs·Recall number Z-1463-2013
da Vinci 5 mm 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,
Published June 12, 2013 · Recall initiated: May 6, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide distribution: US (nationwide) and countries of: Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Netherlands, Norway, South Korea, Sweden, Switzerland, and United Kingdom.
- Lot
- Model number 420011
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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