Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit

Inadequate weld that can potentially cause the product to disassemble.

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification, dated 4/11/25, was distributed to consignees via mail and email. Consignees are being asked to check their inventory for affected devices and immediately quarantine any product identified. Consignees are asked to complete the provided Acknowledgement Form and return it via email to FCA3@integralife.com or by fax to 1-609-750-4220; all consignees are to complete and return the form. Integra asks that the recall notification be forwarded to all users of the devices and to customers who received product that was further distributed. Distributors are to collect completed Acknowledgement Forms from their customers and provide them to the firm. Consignees with any questions can contact Customer Service at 1-800-654-2873 or by email at custsvcnj@integralife.com.

• FDA enforcement recordOfficial FDA database entry for Z-1717-2025
• FDA 510(k) clearance · K073336The device's official FDA premarket clearance record
• FDA device classification · HBFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4305The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Integra LifeSciences Corp. (NeuroSciences)Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.