Class 2 Device Recall Integra Cranial Access Kit

• Date Initiated by Firm: October 19, 2023
• Date Posted: December 06, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0496-2024
• Recall Event ID: 93356
• 510(K)Number: K961113
• Product Classification: Drills, burrs, trephines & accessories (manual) - Product Code HBG
• Product: Integra Cranial Access Kit- For access to the subarachnoid space or the lateral ventricles of the brain.; Catalog Number: INS7250
• Code Information: UDI-DI: 10381780431916 Lot Number/Exp. Date: 6500469 1-Mar-25 6844175 1-Mar-25 7078238 1-May-25
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Lacey Gigante ; 609-212-9004
• Manufacturer Reason for Recall: Defect in the outer packaging of the Cranial Access Kits. can cause the packaging to split without any additional forces outside compromising the sterility of the device
• FDA Determined Cause: Process control
• Action: Integra notified consignees (Hospitals, Government facilities, and Distributors) via Fedex priority overnight on 10/19/23 . Letter titled: 1st Notification- Urgent: Voluntary Medical Device Recall. Letter states reason for recall, health risk and action to take: Actions to be Taken by Customers: 1. If you do have units of the affected product listed in Table 1, remove it immediately from service. 2. If you do have affected product, check the box on the enclosed form I do have affected product. Record the total quantity of the affected product that you have. 3. If you do not have affected product, check the box, I do not have affected product. 4. Complete the attached Acknowledgement Form and return to FCA2@integralife.com or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. When your form is received, and it is noted that you have affected product, Customer Service will contact you and provide a Return Material Authorization (RMA) number and directions to return the affected product. You can request a credit or a replacement for the quantities returned (based on inventory availability). Actions to be Taken by Distributors/Sales Reps: 1. If you do have the affected product listed in Table 1, remove the product from further distribution. 2. Complete the attached acknowledgment form. 3. If you do have affected product, check the box I do have affected product . Record the total quantity of affected product you have. 4. After completion, please email the Acknowledgement Form to FCA2@integralife.com or FAX to 1-609-750-4220. 5. Keep a copy of the form for your records. 6. Please check your customer traceability records for shipments of above catalog and lot numbers. 7. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 8. When the form from you and your customer is received, and it is noted that you or your customer has affected product, Customer Service will c
• Quantity in Commerce: 485 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, Chile, France, Ireland, Israel, South Africa, United Kingdom.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = HBG and Original Applicant = CLINICAL NEURO SYSTEMS LLC.