ConMed Corporation: ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.

Recall number

Z-0331-2014

Recalling firm

ConMed Corporation

Product

ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE -- CONMED CORPORATION 525 FRENCH RD, UTICA, NY 13502 --- The ConMed Altrus Thermal Tissue Fusion System is comprised of a dedicated energy source and disposable handpiece used to ligate (seal) and divide (cut) blood vessels and tissue bundles that fit into the jaws of the handpiece. The Altrus System utilizes a thermal energy platform to achieve the desired clinical effect. The ConMed Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.

Status

Terminated

Initiated

2013-10-23

Posted

2013-11-15

Terminated

2017-03-08

Reason

The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and subsequently distributed. ConMed evaluated the potential risk that this issue could present to the patient and concluded the risk of injury to be negligible; however exposure could cause a minor, local, self correcting infection.

Root cause

Material/Component Contamination

Action

The firm, ConMed, sent an "URGENT: VOLUNTARY DEVICE RECALL" letter dated October 23, 2013 and Business Reply Forms to the domestic consignees/customers via USPS Priority Mail. Distribution of the recall letter to the foreign consignees will follow once the letter has been translated into the different foreign languages. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately stop the use of these devices; review your inventory for any of the devices listed; contact all of those organizations within your facility and any other facilities that you may have supplied or given these affected products to; complete and return the ATTACHMENT I Effectiveness Check Business Reply Form via fax to: ConMed Recall Coordinator at 315-624-3225. If you have any of the affected devices, please complete Attachment I and return it with the devices to: ConMed Corporation, 525 French Road, Utica, NY 13502 Attn. Ed Kovac, Return via: FedEx Account # 487553646. Please indicate with your returned devices, if you are requesting credit or replacement of the devices. Please do not return used devices. If you do not have any devices to return, please complete Attachment I, indicating you have no devices and fax it to 315-624-3225, Attn: ConMed Recall Coordinator. For questions, please contact ConMed Recall Coordinator at 315-624-3237 or e-mail altrus@conmed.com.

Quantity

65 handpieces (Domestic: 41 devices; Foreign: 24 devices)

Distribution

Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.

Lot, serial or model codes

Lot 13CHB007

510(k) numbers

["K101534"]

PMA numbers

not on file

Product code

GEI

Firm FEI

3001451571

Firm city

Utica

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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