Recall Z-0249-2020 — EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
U.S. FDA — Device Enforcement · United States · 2018-06-04 · Class II
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Reported risk: 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.
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