medical Class II Updated 2018-07-18

Intuitive Surgical, Inc. recalls da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G

Recalled Product

da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.

Hazard / Issue

Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this component, the reload knife will not move and cut tissue when the stapler is fired.

Issued by

FDA

Distribution: U.S., foreign and government accounts. Foreign: Australia, Austria, Belgium, Brazil, Canada, China (Hong Kong), Czech Republic, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Luxembourg, Netherlands, Norway, Qatar, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom.
Lot/Code Info: UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020
View official government recall

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