Class 2 Device Recall Head Ring Assembly with Intubation Mounts (HRAIM)

• Date Initiated by Firm: August 09, 2012
• Date Posted: September 20, 2012
• Recall Status: Terminated on March 26, 2014
• Recall Number: Z-2429-2012
• Recall Event ID: 62978
• 510(K)Number: K944463
• Product Classification: Neurological stereotaxic Instrument - Product Code HAW
• Product: Integra HRAIM Head Ring Assembly with Intubation Mounts; ; The CRW stereotactic system is used in conjunction with the HRAIM head ring is a target-centered system that can be configured to be CT-only or CT/MR compatible. The CRW stereotactic system is a multi-purpose system used for localizing intercranial targets for precisely directing instruments such as: Biopsy forceps RF lesioning electrodes Deep brain electrodes Recording and stimulating electrodes
• Code Information: All lot numbers from 2002 to current
• Recalling Firm/ Manufacturer: Integra LifeSciences Corporation; 105 Morgan Ln; Plainsboro NJ 08536-3339
• For Additional Information Contact: David E Gronostajski; 609-275-2700
• Manufacturer Reason for Recall: T-handle screw is used on a complementary product to the CRW, the Integra HRAIM, which is the CT-compatible intubation Head Ring Assembly. When the T-handle on the HRAIM intubation hoop is tightened, the T-handle could stop in a vertical position that prevents the CRWPRECISE and certain models of the CRW-ASL from seating properly on the head ring although it appears to be fully seated
• FDA Determined Cause: Device Design
• Action: The firm, Integra, sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL NOTIFICATION" dated August 10, 2012 to US & Canada consignees/customers via traceable courier service and Non-US & Non-Canada consignees/customers - through written notification delivered either by traceable courier, email, facsimile, or through a directed visit by an Integra Sales Representative. The notification describes the product, problem and actions to be taken. The Integra sales representative will replace the screws according to the attached rework instructions. If for some reason it is not possible to replace the screws during the visit, the sales representative will leave the screws and customers can then replace them by following the attached rework instructions and discard the old screws immediately after replacement. The customers were instructed to complete and return the Product Recall Acknowledgement Form via the sales representatives visit; fax at 1-609-750-7999 or email to: csnirecalls@integralife.com and include the number of devices to be identified and replaced . Note:The T -Handle screws that are replaced will be disposed of at the consignee's/customers location. Please feel free to contact our service hotline at 888-772-7378 should you have any additional questions.
• Quantity in Commerce: 188 units
• Distribution: Worldwide distribution: USA (Nationwide) and countries of: Argentina, Australia, Belgium, Canada, China, Czec, Denmark, France, Hong Kong, Hungary, Italy, Japan, Malaysia, Philippines, Singapore, Spain, South Africa, and UK.
• 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 = HAW and Original Applicant = RADIONICS SOFTWARE APPLICATIONS, INC.