Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0332-2014·Announced 2013-11-27

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.

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 2/5 (Moderate).

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…
Manufacturer: ConMed Corporation
Category: Medical Device — Surgical Instrument
Hazard: contamination
infection

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.

See all 2 products in this recall →

Same manufacturer · ConMed Corporation

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Same hazard · contamination