FDAFDA · Food and drugs·Recall number Z-2675-2016
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).
Published September 7, 2016 · Recall initiated: July 14, 2016
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
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Intuitive Surgical, Inc.
- Distributor
- Worldwide Distribution - US (nationwide) Internationally to Australia, Belgium, Denmark, France, Germany. Italy. Japan, Spain, Sweden, Switzerland, Taiwan, and Turkey,
- Lot
- All model 470298
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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