Integra C7000 CUSA Clarity System Recalled for Drying Time Discrepancy
Integra LifeSciences is recalling 820 C7000 CUSA Clarity systems because the operator manual underestimates the required drying time for sterilization trays.
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 procedural error in the manual that could lead to inadequate sterilization, but no specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Integra LifeSciences Corp. is recalling 820 units of the C7000 - CUSA Clarity Ultrasonic Tissue Ablation System. The recall is due to a discrepancy in the operator manual regarding the drying time for the 36 kHz Sterilization Tray and its components.
The current manual states that a 30-minute cycle is the minimum dry time required. However, the system does not meet the Dry Time Criteria for a 30-minute cycle, and 40 minutes is actually required for complete drying. This issue affects the US Operations Manual (P/N 60905197).
The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. Users should refer to the updated instructions to ensure the 40-minute drying cycle is used for complete drying of the sterilization tray and components.
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)
- US Ops Manual P/N 60905197
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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