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FDA (Device enforcement)Recalled 2023-10-06class ii

Intuitive Surgical, Inc.: Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Hazard

There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Details from the source

Reason for recall: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement. Distribution: US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea Quantity: 317 units Lot/code info: UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

UPC codes

00886874113752

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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