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Easy Cut Splint

Tacklebox Medical, LLC · Model 2513155 · UDI-DI 00198715553499

LYA Prescription

510(k) clearances

203

Adverse events (3 deaths)

Recalls

105

Facilities

Description

The Easy Cut Intranasal Splint is designed to maintain a nasal airway and provide septal support post-operatively after septal and/or cosmetic nasal surgery. As an added feature, the anterior tip of each splint has an elevated suture channel for suture placement through the splint and septum to prevent posterior dislodgement. The elevated suture channel provides easy access to the suture and aids in suture removal. Each splint has an elevated suture channel on each end so that a splint can be used on the right or left side. The splints are supplied sterile in packages containing two (2) splints. There are five (5) packages in a box.

Recalls

Date	Firm	Reason
2022-07-27	GELITA MEDICAL GMBH	In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
2006-07-11	Porex Surgical, Inc.	Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material

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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.