—#207240

Product

Integra Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND

FDA product code: HBG — Drills, Burrs, Trephines & Accessories (Manual)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K961113
Affected lot / code info: UDI-DI: 10381780263906 Lot Number/Exp. Date: 7257032 07/16/2025 ; 7275713 09/03/2025 ; 7291974 09/03/2025; 7312131 09/03/2025; 7289690 09/03/2025; 7291975 09/03/2025; 7312137 09/03/2025 7312139 09/03/2025

Why it was recalled

Potential holes and tears in the sterile packaging (header bag) of the Cranial Access Kit may compromise the sterility of the device.

Root cause (FDA determination)

Process control

Action the firm took

Integra LifeSciences issued First Notification: Urgent: Voluntary Medical Device Recall Letter delivered by courier service, facsimile or email between April 17th and April 18th, 2024. Letter states reason for recall, health risk and action to take: 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. If you do not have affected product, check the box, I do not have affected product. 5. After completion, please email the Acknowledgement Form to FCA3@integralife.com or FAX to 1-609-750- 4220. 6. Keep a copy of the form for your records. 7. Please check your customer traceability records for shipments of above catalog and lot numbers. 8. Forward a copy of the enclosed Field Safety Notice to any of your customers that have purchased the above catalog and lot number. 9. 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 contact you or your customer and provide an RMA number and directions to return the product. You can request a credit for the quantities returned. Receipt of this form ensures that Integra has achieved a level of effectiveness in communicating this information. We recommend you also maintain a copy of this notification and the signed copy of the acknowledgement form for your records. Should you have any questions regarding these instructions, please contact Customer Service: Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: custsvcnj@integralife.com

Recalling firm

Firm: Integra LifeSciences Corp.
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of CA, BE, CL.

Timeline

Recall initiated: 2024-04-17
Posted by FDA: 2024-05-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #207240. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.