da Vinci Xi EndoWrist Stapler 45 Reload Blue, Model 48645B-03, 12 reloads/box.
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling da Vinci Xi Stapler 45 Blue and Green Reloads because some units may be missing a component of the knife mechanism. When this component is missing, the knife will not move and cut tissue when the stapler fires during surgery. The recall affects 7,337 devices distributed across U.S. and international accounts including 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, and the United Kingdom.
The affected devices have UDI 00886874112878 and expiration dates between October 14, 2017 and February 21, 2020. The source document does not specify a remedy or what consumers should do in response to this recall.
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: 7337 Lot/code info: UDI: 00886874112878. 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.