Integra LifeSciences Recalls CUSA Clarity Ultrasonic Tissue Ablation Systems
Integra LifeSciences is recalling 820 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
What this means for you
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 the hazard involves a sterilization drying time discrepancy in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall involves the 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) and the associated Italian OPS Manual (P/N 60905773). The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong.
The recall was initiated because the 36 kHz Sterilization Tray system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30 minutes as the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components, but 40 minutes is required for complete drying.
This is a Class II recall, which means use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- Manufacturer
- Integra LifeSciences Corp.
- Affected units
- 820
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)
- Italian OPS Manual P/N 60905773
Distribution
Part of a larger recall action
This product is one of 42 recalled by Integra LifeSciences Corp. 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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