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Intuitive Surgical, Inc. Recall 89641

Description: VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422

Intuitive Surgical, Inc. Recall 89641 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1209-2022
Event ID89641
Event DescriptionVESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.
Quantity140,519 boxes (843,113 individual units)
Recall ReasonPlacing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.
Device Classification20220608
Device Code InfoUDI: 00886874115664. All lots
Center Classification Date20220531
Recall Initiation Date20220303
Recalling FirmIntuitive Surgical, Inc.
Initial Notification Letter
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