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EMI Super Micro TAKUMI Model

EMI FACTORY CO., LTD. · Model EMI087TA · UDI-DI 04582486865015

FHQ

510(k) clearances

1,038

Adverse events

Recalls

343

Facilities

Description

The product is intended to be used for the purpose of grasping the suture needle during suturing. It also includes a cutting portion for cutting the suture attached to the suture needle. Therefore, it is possible to switch between the suture needle clamping function and the suture thread cutting function while holding the needle holder without removing the instrument from the field of view.

Recalls

Date	Firm	Reason
2020-06-26	Boss Instruments, Ltd.	The tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure.
2020-06-03	Dufner Instrumente GmbH	Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
2017-05-01	Cook Inc.	COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfecti
2009-07-30	Davol, Inc., Sub. C. R. Bard, Inc.	Product sterility may be compromised due to lack of package integrity.

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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.