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Medeon

MEDEON BIODESIGN, INC. · Model M12 · UDI-DI 04719872920014

HCF GCJ OCW Prescription

510(k) clearances

642

Adverse events (6 deaths)

Recalls

164

Facilities

Description

The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site. The AbClose - Port Site Closure Device is intended to be used by clinicians through prescription use only.

Recalls

Date	Firm	Reason
2023-12-29	Aesculap Inc	Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short
2023-12-29	Aesculap Inc	Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short
2020-07-08	New Wave Endo-Surgical, Corp.	The plastic housing on the device may fracture
2016-11-16	Teleflex Medical	The devices wings may become partially detached from the EFx Shield during use.
2016-03-24	Teleflex Medical	Incorrect expiration date was printed on the product label.

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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.