Home / Recalls / Intuitive Surgical, Inc. / Z-0249-2020

Z-0249-2020 Class II Ongoing

Recalled by Intuitive Surgical, Inc. — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
November 6, 2019
Initiation Date
June 4, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3108 units (518 boxes of 6 units)

Product Description

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Reason for Recall

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Distribution Pattern

Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.

Code Information

Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

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