Z-0331-2014Class II

ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE...

Name: Z-0331-2014 ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF 60-9520-001, STERILE...
Creator: ConMed Corporation
Published: 2013-10-23
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2013-10-23 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of 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... on 2013-10-23. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0331-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-23
Posted: 2013-11-15
Terminated: 2017-03-08
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.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 65 handpieces (Domestic: 41 devices; Foreign: 24 devices)
Distribution: Worldwide distribution: US (Nationwide) and countries of: Canada, Germany and Italy.
Product codes and lots: Lot 13CHB007

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0331-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0331-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15
Z-0332-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-15

Product code GEI

K101534Class IIConmed Altrus Thermal Tissue Fusion SystemConmedcorp / cleared 2010-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)