CLASS II Device recall · Reported 18 Dec 2019 · FDA Enforcement Report
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System recalled
Integra LifeSciences is recalling C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System, distributed in 31 states. The recall was initiated on 21 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0635-2020
- FDA event ID
- 84216
- Recalling firm
- Integra LifeSciences, Plainsboro, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Oct 2019
- FDA classified
- 8 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 21 Oct 2019 | Recall initiated by company | |
| 8 Dec 2019 | Classified by FDA | +48 days |
| 18 Dec 2019 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
Where it was distributed
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
AlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Portuguese OPS Manual P/N 60905779
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
41 other products · FDA event 84216This product is part of a recall event; the main page for the event is C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System recalled.
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