Recall Z-0649-2020
Integra LifeSciences Corp. · initiated October 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
C7000 - CUSA Clarity Ultrasonic Tissue Ablation System
Codes / lots: Croatian OPS Manual P/N 60905786
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.
FDA-determined cause: Device Design
Action taken
All impacted consignees (Hospitals, Distributors and Sales reps) were notified by letter delivered by courier service (2nd day), facsimile or email between October 21st and 23rd, 2019. URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION CUSA Clarity Operators Manual Dear Valued Customer/Distributor: The purpose of this letter is to advise you that Integra LifeSciences is voluntarily conducting this field corrective action for the Operators Manuals associated with C7000 CUSA Clarity Console. It was discovered through internal review that we need to revise the Operators Manual to reflect the most accurate sterilization parameters and hence the dry time parameters have been changed from 30 minutes to 40 minutes for the CUSA Clarity 36kHz handpiece and components consistent with the CUSA Clarity 23kHz handpiece and components. There is an improbable likelihood that serious injuries could occur due to the corrections identified within this field action. The internal review confirms that there have been no adverse events or complaints that Integra LifeSciences is aware of associated with the dry cycle time noted in the current Operators Manuals, nor have there been any reports of serious injuries or deaths related to this issue. While it is highly unlikely that a shortened dry time will result in a non-sterile product given that the drying occurs after the steam application, it may result in visible moisture (most likely on the outer wrap). Sterilization Dry Time moisture may be detected by inspection of components and the outer wrap for visible moisture or water. Where visible moisture is noted the product should be re-wrapped and re-sterilized. We request you take the following actions: 1. Customers a. Please review and understand the information provided in Appendix 1. b. Review The Sterilization Parameters in Section 11 of your Operators Manual. c. Replace the information in Section 11 of your Operators Manual with the information
Details
- Recall number
- Z-0649-2020
- Initiated
- October 21, 2019
- Terminated
- May 7, 2020
- Product code
- LFL – Instrument, Ultrasonic Surgical
- 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
- Recalling firm
- Integra LifeSciences Corp., Plainsboro, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0613-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0614-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0615-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0616-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0617-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0618-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0619-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0620-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0621-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0622-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0623-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0624-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0625-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0626-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0627-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0628-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0629-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0630-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0631-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0632-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0633-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0634-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0635-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0636-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0637-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0638-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0639-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0640-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0641-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |
| Z-0642-2020 Class II | C7000 - CUSA Clarity Ultrasonic Tissue Ablation SystemThe 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for… | 10/21/2019Terminated |