Class 1 Device Recall CODMAN Disposable Perforator 9mm

• Date Initiated by Firm: September 26, 2025
• Date Posted: November 03, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0374-2026
• Recall Event ID: 97623
• 510(K)Number: K183581
• Product Classification: Drills, burrs, trephines & accessories (compound, powered) - Product Code HBF
• Product: CODMAN Disposable Perforator 9mm. Cranial Perforator.
• Code Information: Model No. 261223; UDI: 10381780513605; Lot No. 5828553, 6264478, 6264481, 6264482, 7230672, 7230673, 7230674, 7230675, 7261971, 7268008, 7268009, 7268010, 7268011, 7268012, 7268013, 7268014, 7268015, 7268016, 7268017, 7268018, 7268019, 7282954, 7282955, 7293422, 7293423, 7293424, 7293425, 7293426, 7293427, 7293428, 7300667, 7300668, 7300669, 7300670, 7300672, 7300673, 7300674, 7371082, 7371083, 7379652, 7379922, 7379923, 7379924, 7379926, 7379928, 7379660, 7379925, 7379927, 7450559, 7450560, 7450561, 7450562, 7450563, 7450564, 7450565, 7450566, 7451273, 7451274, 7451275, 7451276, 7451277, 7451278, 7451279; Expiration Date: 2024-03-31 to 2029-07-31.
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp. (NeuroSciences); 1100 Campus Rd; Princeton NJ 08540-6650
• For Additional Information Contact: Mary O'Neill; 1-609-275-0500
• Manufacturer Reason for Recall: Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
• FDA Determined Cause: Process change control
• Action: An URGENT: MEDICAL DEVICE RECALL notification dated 9/26/25 was mailed to consignees. Customers with affected devices are to be immediately removed and quarantined. Customers are to send their completed Acknowledgement Form to FCA3@integralife.com or by fax at 1-609-750-4220. Forward the recall notification to those who use the product for their awareness. Integra Customer Service will reach out to consignees to facilitate product return. Distributors and Sales Representatives with affected devices are to remove product from further distribution. They are to send their completed Acknowledgement Form to FCA3@integralife.com or by fax at 1-609-750-4220. Distributors are to create an acknowledgement form from the distributor to their customers and provide them with a copy of the recall notification. Sales Representatives are to receive further directions from Integra Customer Service after their Acknowledgement Form has been received. Consignees with any questions are to call 1-800-654-2873 or email custsvcnj@integralife.com.
• Quantity in Commerce: 5,109 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Ecuador, France, French Guiana, Germany, Greece, India, Ireland, Italy, Japan, Jordan, Korea, Lithuania, Mexico, Morrocco, Netherlands, New Zealand, Palestine, State of, Philippines, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan , Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Vietnam.
• 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 = HBF