Recall Z-0359-2016— ConMed Corporation

Name: FDA recall Z-0359-2016
Creator: U.S. Food and Drug Administration
Published: 2015-11-05

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2015-11-05, terminated 2018-05-24. It names one FDA 510(k) clearance: K140459. Product: Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.. Reason: 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..

Recalling firm: ConMed Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-11-05
Terminated: 2018-05-24
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K140459 — ALTRUS THERMAL TISSUE FUSION ENERGY SOURCE, ALTRUS THERMAL TISSUE FUSION HANDPIECE, ALTRUS THERMAL TISSUE FUSION SYSTEMConmed Corporation·cleared 2014-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.