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GEM Microvascular Anastomotic COUPLER Sterilization Tray

SYNOVIS MICRO COMPANIES ALLIANCE, INC · Model GEM 2745 · UDI-DI 00844735002829

KCT Prescription

510(k) clearances

343

Adverse events

Recalls

292

Facilities

Description

A reusable, single tier sterilization tray, consisting of an anodized aluminum base and cover with instrument holder bars. The tray is designed to hold the Anastomotic Instrument, Vessel Measuring Gauge, and up to two Coupler Forceps for steam sterilization and storage between uses.

Recalls

Date	Firm	Reason
2025-05-23	Jewel Precision Sheet Metal & Machining Co, Inc.	The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., model number: JP-24-8) was not cleared by the FDA. The letter to file justifying the ch
2025-05-22	Jewel Precision Sheet Metal & Machining Co, Inc.	The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
2025-05-01	Implant Direct Sybron Manufacturing LLC	The Drill stop kit contains incorrect components.
2023-04-06	Karl Storz Endoscopy	Metal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the tra
2023-04-05	Karl Storz Endoscopy	Plastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the first time specific to the t
2023-01-30	Carefusion 2200 Inc	Product did not meet shelf-life testing requirements resulting in a breach of the sterility of the Genesis container holding surgical equipment.
2022-09-26	Carefusion 2200 Inc	Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
2022-09-26	Carefusion 2200 Inc	Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
2022-09-26	Carefusion 2200 Inc	Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.
2022-09-26	Carefusion 2200 Inc	Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing.

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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.