Integra LifeSciences Recalls C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the required drying time criteria.
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. The hazard involves a sterilization drying time discrepancy, which is a low-risk contamination issue without reported illnesses or injuries, fitting the criteria for a Moderate severity score.
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 French OPS Manual (P/N 60905770). The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong.
The recall is due to a defect in the sterilization process. The 36 kHz Sterilization Tray system does not meet the Dry Time Criteria for a 30-minute drying cycle. While the current CUSA Clarity Operators manual states that 30 minutes is the minimum dry time for the 36 kHz Sterilization Tray and components, 40 minutes is actually required for complete drying.
Healthcare facilities and users of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System should stop using the affected 36 kHz Sterilization Tray and contact Integra LifeSciences Corp. for further instructions.
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)
- French OPS Manual P/N 60905770
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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