CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
FDA device recall Z-1717-2025 · posted 2025-05-06 · Open, Classified
Recall details
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Reason for recall
- Inadequate weld that can potentially cause the product to disassemble.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HBF
- Quantity affected
- 1,840 units
- Distribution
- Worldwide distribution - US Nationwide including Puerto Rico and the countries of Argentina, Australia, Austria, Bahamas, Barbados, Belgium, Brazil, Canada, Chile, Colombia, Cyprus, Czechia, Dominican
- Date initiated
- 2025-04-11
- Date posted
- 2025-05-06
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 (K073336) | Codman & Shurtleff, Inc. | 2008-01-04 |