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LEVEL ONE TRANSBUCCAL

KLS-Martin L.P. · Model 99-569-97-02 · UDI-DI 00888118097477

GEA Prescription

510(k) clearances

1,045

Adverse events (1 deaths)

Recalls

378

Facilities

Description

CANNULA, RIB, 2.3 MM, DOUBLE POINTED, FOR 99-569-97-01

Recalls

Date	Firm	Reason
2024-12-03	Sklar Instruments	Reports of various packaging issues that may result in a breach of the sterile barrier.
2021-04-01	CLINICAL LASERTHERMIA SYSTEMS AB	single use devices labeled as sterile may not have been adequately sterilized
2020-01-15	Cardinal Health 200, LLC	Non-sterile product was shipped to customers. Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile
2019-07-16	TeDan Surgical Innovations LLC	There was incorrect raw material used in the production of the identified lot.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.
2018-08-21	Genicon, Inc.	There is potential for the plastic optical tip to become detached from the metal shaft.

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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.