Z-2675-2016Class II

STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist...

Name: Z-2675-2016 STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist...
Creator: Intuitive Surgical, Inc.
Published: 2016-07-14
License: https://open.fda.gov/license/

Intuitive Surgical, Inc. / initiated 2016-07-14 / Terminated / root cause: manufacturing process

FDA source

Intuitive Surgical, Inc. began a recall of STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler... on 2016-07-14. FDA classified it as Class II and gives the reason as "Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2675-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2016-08-26
Terminated: 2017-01-03
Recalling firm: Intuitive Surgical, Inc.
Product: STAPLER,IS4000; Model number 470298; General and Plastic Surgery: The Intuitive Surgical da Vinci EndoWrist Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci Xi Surgical System (Model IS4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic, and Urologic surgery. The device can be used with staple line or tissue butressing material (natural or synthetic).
Product code: NAY System, Surgical, Computer Controlled Instrument
Reason for recall: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Intuitive sent a Stop Use e-mail to all affected sites on July 14, 2016 to inform users of the issue prior to the commencement of a recall. E-mail described the problem and asked that all surgeons who use the stapler be informed to immediately stop use. Formal letters will follow. Medical Device Recall letters were sent on July 21, 2016. Customers were instructed to return quarantined affected product whether used or unused to Intuitive Surgical. Customers should contact customer service to initiate the standard Return Material Authorization (RMA) process by phone or email: North and South America: 800-876-1310, option 3 (6AM to 5PM PST) Email: [email protected] Europe, Middle East, Asia and Africa Phone: 800-821-2020 or +41 21 821 2020 Email: [email protected] Customers were also instructed to complete the attached Return Acknowledgement Form and submit via email to Regulatory Compliance at [email protected] or by fax to +1 (408) 523-0619. For questions regarding this recall call 408-523-2100. 10-31-16 Update: Monthly status update states that an additional 93 instruments have been identified and an additional communication will be sent to these sites in Mid November 2016,
Quantity in commerce: 875 instruments (827 a la carte + 48 in kits) total, all models
Distribution: Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
Product codes and lots: All model 470298

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2675-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2675-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26
Z-2676-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26
Z-2677-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-26

Product code NAY

K140553Class IIEndowrist Stapler 45 and Stapler 45 ReloadsIntuitive Surgical, Inc. / cleared 2014-07-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)