FDAFDA · Food and drugs·Recall number Z-1426-2013
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial and total thyroidectomy procedures, including endoscopic and video assisted procedure that are preferable to conventional (open) procedures that utilize a cervical incision because they leave no visible neck scar.
Published June 5, 2013 · Recall initiated: October 13, 2011
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
Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- USA Nationwide distribution
- Lot
- NA - marketing and promotional only.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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