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Panel PC

EVENTUM ORTHOPAEDICS LTD · Model PC001 · UDI-DI 05065012584516

ONN Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Medical computer loaded with Quadsense software.

Recalls

Date	Firm	Reason
2018-07-12	Orthosensor, Inc.	Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2018-07-12	Orthosensor, Inc.	Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2018-07-12	Orthosensor, Inc.	Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2018-07-12	Orthosensor, Inc.	Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2018-07-12	Orthosensor, Inc.	Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2018-07-12	Orthosensor, Inc.	Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.
2014-12-05	Orthosensor, Inc.	Presence of one inoperable (dead) sensor pad.
2012-02-04	Orthosensor	Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer f

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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.