The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0613-2020·Announced 2019-12-18

Integra C7000 CUSA Clarity System Recalled for Inadequate Sterilization Tray Drying

Integra LifeSciences is recalling 820 C7000 CUSA Clarity Ultrasonic Tissue Ablation Systems because the 36 kHz Sterilization Tray does not meet the 30-minute drying time criteria stated in the manual.

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 is a labeling error regarding drying time, which is a documentation issue that may lead to temporary adverse health consequences if the equipment is not dried properly, fitting the criteria for a moderate severity recall.

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 US Operations Manual (P/N 60905769). The devices 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 discrepancy in the drying time required for the 36 kHz Sterilization Tray and its components. The current CUSA Clarity Operator's manual states that a 30-minute drying cycle is the minimum required for complete drying. However, the system does not meet the Dry Time Criteria for a 30-minute cycle; 40 minutes is actually required for complete drying. This labeling error could result in incomplete drying of the sterilization tray components.

Healthcare facilities and users who have purchased or received these devices should stop using the affected sterilization trays and contact Integra LifeSciences for further instructions. The recall is classified as Class II by the FDA, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Manufacturer
Integra LifeSciences Corp.
Category
Medical Device — Surgical Instrument
Hazard
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 60905769

Distribution

Distributed in 36 states:

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.

See all 42 products in this recall →

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