Z-0359-2016Class II

Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal...

Name: Z-0359-2016 Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal...
Creator: ConMed Corporation
Published: 2015-11-05
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2015-11-05 / Terminated / root cause: manufacturing process

FDA source

ConMed Corporation began a recall of Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source on 2015-11-05. FDA classified it as Class II and gives the reason as "Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal"...". 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-0359-2016
Classification: Class II
Status: Terminated
Initiated: 2015-11-05
Posted: 2015-12-01
Terminated: 2018-05-24
Recalling firm: ConMed Corporation
Product: Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature as higher than the actual handpiece's temperature. This causes some devices to generate a "Check Seal" message with an audible alarm and to stop the heating cycle.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On November 4, 2015, ConMed Corporation distributed Urgent Device Recall Notification letters dated November 5, 2015 to their customers via overnight courier service. Customers should stop the use of these devices immediately. The recall notice recipient should contact all organizations within their facility and any other facilities that may have received the affected products. It is imperative that all end users of these devices receive this notice and respond immediately. Customers with questions can call Patricia Cotter, ConMed Recall Coordinator 315-624-3237 (8AM - 5PM EST, Monday through Friday), or fax to 315-624-3225 or email [email protected]. Customers who have any of the devices subject to recall (listed on the recall notice-attachment I) should immediately contact their sales representative. The sales representative will deliver a replacement unit to your facility and will pick up and return the recalled devices to ConMed Corporation. If you are unable to reach your sales representative, please contact Patricia Cotter at the numbers above. If you do not have any devices to return, customers should complete the Business Reply Form (attachment II), indicating you have no devivces and fax it to 315-624-3225, Attn: Patricia Cotter.
Quantity in commerce: 9 devices
Distribution: Distributed in the states of CA, and TX and in the country of Mexico.
Product codes and lots: Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0359-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0359-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-09	2015-12-01

Product code GEI

K140459Class IIAltrus Thermal Tissue Fusion Energy Source, Altrus Thermal Tissue Fusion Handpiece, Altrus Thermal Tissue Fusion SystemConmed Corporation / cleared 2014-07-11

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)