Integra C7000 CUSA Clarity System Recalled for Drying Time Error
Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the operator manual lists an incorrect minimum drying time for sterilization trays.
What this means for you
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 source text describes a documentation error regarding drying times without reporting any illnesses, injuries, or hospitalizations. Per the rubric, this fits the criteria for a moderate severity score involving minor labeling or documentation issues.
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 CUSA Clarity Operators manual regarding the minimum dry time for the 36 kHz Sterilization Tray and 36 kHz Components.
The manual currently states that 30 minutes is the minimum dry time required for a 30-minute drying cycle. However, the system does not meet the Dry Time Criteria for this duration; 40 minutes is required for complete drying. This error could result in incomplete drying of the components.
The affected units were distributed in the United States and internationally to Singapore, Mexico, Canada, Japan, Australia, Colombia, Thailand, and Hong Kong. The specific code information associated with the recall is the Japanese OPS Manual P/N 60905204. Users should contact the manufacturer for instructions on how to proceed.
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)
- Japanese OPS Manual P/N 60905204
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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