Device recall

Z-1348-2008: Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical…

FDA device recall · Class II · Intuitive Surgical, Inc.

Key facts

Recall number (Z-number) Z-1348-2008
Recall event 46890
Product Da Vinci S 8mm Instrument Cannula with outlet for use with the Da Vinci Surgical System; Model IS2000, Part Numbers: 400254-01, 400255-01; Used in endoscopic surgery to establish a port of entry for Intuitive Surgical's EndoWrist Instruments. Product is distributed by Intuitive Surgical, Inc…
Product code NAY
Recalling firm Intuitive Surgical, Inc.
Recall class Class II
Status Terminated
Termination date Mar 31, 2011
510(k) numbers K012036
FEI number 3001675293

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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