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ACE Medical

Ebner Medical, LLC · Model AA9991415 · UDI-DI 00840217906913

GEA Prescription

510(k) clearances

1,049

Adverse events (1 deaths)

Recalls

382

Facilities

Description

Micro Injection Needle Style "V" Dissector 14ga by 15 cm Luer Lock

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.