Class 2 Device Recall C7000 CUSA Clarity Console

• Date Initiated by Firm: October 21, 2019
• Create Date: December 08, 2019
• Recall Status: Terminated on May 07, 2020
• Recall Number: Z-0650-2020
• Recall Event ID: 84216
• 510(K)Number: K182809
• Product Classification: Instrument, Ultrasonic Surgical - Product Code LFL
• Product: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
• Code Information: Croatian OPS Manual P/N 60905214
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: Dr. Patricia Kihn; 717-309-3966
• Manufacturer 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: 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
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LFL and Original Applicant = Integra LifeSciences Corporation