OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

Integra issued an URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice to its consignees on 06/05/2026 via overnight mail. The notice explained the issue, hazards and risks, and requested the following: "Customer/Medical Facility-Actions to Take: 1. If your facility has validated its own sterilization process, it is in your discretion to follow your validated process recognizing that Integra LifeSciences has only validated the sterilization process noted below. 2. If utilizing the Gravity Sterilization Method, stop using this method immediately. The Gravity Sterilization Method for sterilizing Omni-Tract devices is not effective. 3. Replace the instructions in the current IFUs (40-9015 Rev BAA and 40-6008 Rev AAA) for 'sterilization' sections with the following: Sterilization Following proper cleaning and prior to sterilization, use an appropriate sterilization wrap with sterilization tray to ensure that components and devices are not damaged in transportation to and from the sterilizer. NOTE: Validation was completed using a wrapped sterilization tray and not a rigid container. Steam Sterilization Method: Process Validation procedures followed ANSI/AAMI ST79 standards for Prevacuum. Steam Sterilization is the validated method for sterilizing Omni-Tract products in a wrapped tray. No other methods have been validated and approved for use with Omni-Tract products. NOTE: Instruments, regardless of sterilization cycle used, will remain too hot for immediate use. Allow sufficient dry time and cooling before use. Prevacuum: Utilize one of the Prevacuum sterilization cycles listed in Table 2 to ensure the Omni-Tract Surgical Retractor Systems are properly sterilized after use. Table 2: Prevacuum Sterilization Cycle Parameters Cycle Type Temperature Exposure Time Dry Time (minimum) Prevacuum 270F (132C) 4 minutes 90 minutes Prevacuum 273F (134C) 3 minutes 110 minutes Prevacuum 273F (134C) 18 minutes 120 minutes 4. Complete the Acknowledgement Form included in Ap