Recall Z-1717-2025 ยท HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
| Date | May 6, 2025 (initiated Apr 11, 2025) |
| Status | Open, Classified |
| Reason | Inadequate weld that can potentially cause the product to disassemble. |
| Root cause | Process control |
| Action | 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. Distrib |
| Quantity | 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 Republic, Ecuador, El Salvador, France, French Guiana, Germany, Ghana, Greece, Hong Kong, India, I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073336 | CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 Codman & Shurtleff, Inc., Jan 4, 2008 |