# FDA recall Z-0613-2020

> **Integra LifeSciences Corp.** · Class II · device recall initiated 2019-10-21.

## Product

C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System

## Reason for recall

The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operator s manual states 30 minutes for the minimum Dry Time for the 36 kHz Sterilization Tray and 36 kHz Components but 40 minutes is required for complete drying.

## Distribution

US: AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS NC NE NJ NY OH OK OR PA SC TN UT VA WA WI WV    International: SG MX CA JP AU CO TH HK

## Key facts

- **Recall number:** Z-0613-2020
- **Recalling firm:** Integra LifeSciences Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-21
- **Report date:** 2019-12-18
- **Termination date:** 2020-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plainsboro, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0613-2020

## Citation

> AI Analytics. FDA recall Z-0613-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0613-2020. Source: US FDA. Licensed CC0.

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