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Aortic Prosthesis Indexing Cone

Coroneo Inc · Model 1010605 · UDI-DI 10817121000171

FTY Prescription
10
510(k) clearances
436
Adverse events
5
Recalls
400
Facilities

Description

The Aortic Prosthesis Indexing Cone is a medical device that is intended to be used to facilitate the location and cutting of two or three equally spaced features on an extremity of an aortic graft prosthesis having a diameter within the range of 20 mm to 34 mm.

Recalls

DateFirmReason
2015-03-05SpineFrontier, Inc.The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used incorrectly as the Surgical Technique does not adequately convey the intended use
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.
2010-10-22Lemaitre Vascular, Inc.Box label (Top Part). Lot and Expiration Date information were switched.

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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.