CLASS II Device recall · Reported 9 Dec 2015 · FDA Enforcement Report
Altrus Thermal Tissue Fusion Energy Sources recalled by ConMed
ConMed is recalling Altrus Thermal Tissue Fusion Energy Sources, distributed in California, Texas. The recall was initiated on 5 Nov 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0359-2016
- FDA event ID
- 72586
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Nov 2015
- FDA classified
- 1 Dec 2015
- Reported
- 9 Dec 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2015 | Recall initiated by company | |
| 1 Dec 2015 | Classified by FDA | +26 days |
| 9 Dec 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Altrus Thermal Tissue Fusion Energy Sources, Catalog Numbers: 1) 60-9500-120 & 2) 60-9500-INT. Thermal Ligation and Cutting Energy Source.
Where it was distributed
Distributed in the states of CA, and TX and in the country of Mexico.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 1) 15090103 & 15150005, 15150006, 15150007, 15150008, 15150009, 15150010, 15150011, 15150012, 15130004, 15250013, 15250014, 15250015, 15250016, 15250017, 15300018 & 15300020, 2) 15050001, 15300005 & 15300006
Where was it sold?
Distributed in the states of CA, and TX and in the country of Mexico.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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