# FDA recall Z-0641-2020

> **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 Operators 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-0641-2020
- **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-0641-2020

## Citation

> AI Analytics. FDA recall Z-0641-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0641-2020. Source: US FDA. Licensed CC0.

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