Altrus Thermal Tissue Fusion Energy Sources — Class II medical device recall Z-0359-2016
Terminated recall by ConMed Corporation, reported 2015-12-09, distributed in CA, TX. Miscalibration of the Energy Source monitoring function, which may incorrectly sense the handpiece temperature
| Recall number | Z-0359-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2015-11-05 |
| Classified | 2015-12-01 |
| Reported by FDA | 2015-12-09 |
| Terminated | 2018-05-24 |
| Distributed | CA, TX |
| Countries outside the US | MX |
| Quantity | 9 devices |
| Reason classes | packaging |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0359-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.