ConMed Recalls Altrus Thermal Tissue Fusion Handpieces Due to Burn Risk
ConMed Corporation is recalling Altrus Thermal Tissue Fusion Handpieces due to a risk of burns. The recall covers 12,653 units distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of burns, which is a risk-of-harm product where injury has not yet been reported in the source text, fitting the High severity criteria.
Plain-English summary
ConMed Corporation has initiated an urgent medical device correction for Altrus Thermal Tissue Fusion Handpieces. The recall is being conducted because the devices pose a risk of burns to patients or medical professionals. The affected products include six specific catalog numbers ranging from 60-9510-001 to 60-9522-001, with dimensions varying between 5 mm and 10 mm in width and 16 cm to 36 cm in length.
A total of 12,653 units are subject to this recall, with 10,769 units distributed domestically and 1,884 units distributed internationally. The products were distributed worldwide and are packaged in cartons containing six units each. All lot codes are affected by this correction.
Healthcare facilities and distributors should stop using the affected handpieces immediately. ConMed Corporation is the recalling firm responsible for managing this urgent medical device correction.
The recalled product
- Product
- Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16 cm Catalog Number: 60-9510-001, 2) 10 mm x 23 cm Catalog Number: 60-9511-001, 3) 10 mm x 36 cm Catalog Number: 60-9512-001, 4) 5 mm x 16 cm Catalog Number 60-9520-001, 5) 5 mm x 23 cm…
- 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)
- all lot codes
Distribution
Distribution scope not specified by the agency.
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