FDAClass IIJune 5, 2013

Thyroidectomy Indication for the da Vinci Surgical recall

Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial…

Why was Thyroidectomy Indication for the da Vinci Surgical recalled?

Promotional literature for use of the da Vinci system for thyroidectomy, which had not been approved with a change to the 510(k).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

NA - marketing and promotional only.

Product
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery for both partial…
Recalling firm
Intuitive Surgical, Inc.
Quantity
2,423 consignee
Distribution
USA Nationwide distribution
Recall date
June 5, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls