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CUSA® NXT

INTEGRA LIFESCIENCES (IRELAND) LIMITED · Model NXT3220 · UDI-DI 10381780039488

LFL Prescription
10
510(k) clearances
68,850
Adverse events (81 deaths)
109
Recalls
141
Facilities

Description

The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

Recalls

DateFirmReason
2026-03-06Integra LifeSciences Corp. (NeuroSciences)Software issue that renders the touch screen unresponsive.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.
2025-10-22Olympus Corporation of the AmericasFirm is initiating a removal due to continued reports of adverse events.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.