ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Particulate Matter
ConMed is recalling 147 Altrus Thermal Tissue Fusion handpieces because they were exposed to higher-than-acceptable particulate matter during manufacture.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the manufacturer concluded the risk of injury is negligible and the potential harm is a minor, self-correcting infection, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ConMed Corporation is recalling 147 units of the Altrus Thermal Tissue Fusion Handpiece (REF 60-9522-001, Lot 13CHB006). The affected devices are sterile, single-use handpieces used in open general surgical procedures to seal and cut blood vessels and tissue.
The recall was initiated because the affected lots were exposed to a higher than acceptable level of particulate matter during manufacture. ConMed evaluated the potential risk and concluded that the risk of injury is negligible, though exposure could cause a minor, local, self-correcting infection.
The devices were distributed worldwide, including nationwide in the United States and in Canada, Germany, and Italy. A total of 135 devices were distributed domestically and 12 were distributed internationally.
The recalled product
- 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 us
- Manufacturer
- ConMed Corporation
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 13CHB006
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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