da Vinci Xi EndoWrist Stapler 45 Reload Green, Model 48445G-03, 12 reloads/box.
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling 6,816 da Vinci Xi EndoWrist Stapler 45 Reload Green units (Model 48445G-03) distributed in the U.S. and multiple foreign countries. The recalled devices may be missing a component of the knife mechanism, which would prevent the knife from moving and cutting tissue when the stapler is fired. The affected devices have a UDI of 00886874112823 and expiration dates between October 14, 2017 and February 21, 2020.
The source document does not specify a remedy for consumers who have this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. 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. Quantity: 6816 Lot/code info: UDI: 00886874112823. Device expiration: 10/14/2017 02/21/2020
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.