ALTRUS¿ THERMAL TISSUE FUSION — Class II medical device recall Z-0332-2014
Terminated recall by ConMed Corporation, reported 2013-11-27, distributed nationwide. The affected lots were exposed to a higher than acceptable level of particulate matter during manufacture and
| Recall number | Z-0332-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2013-10-23 |
| Classified | 2013-11-15 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2017-03-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, IT |
| Reason classes | specification failure |
| Lot numbers | 13CHB006 |
| Model numbers | 60-9522-001 |
Product
ALTRUS¿ THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF 60-9522-001, 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.
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.
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-0332-2014. 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.