FDA Device recall Z-0613-2020
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
- FDA Device
- Class II
- terminated
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System by Integra Lifesciences, citing 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 st….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0613-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-21 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences |
| Distribution | 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 |
Product
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Reason
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.
Identifiers
| code_info | US Ops Manual P/N 60905769 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0613-2020%22
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