Recall Z-0374-2026 ยท HBF Drills, Burrs, Trephines & Accessories (Compound, Powered)
Integra LifeSciences Corp. (NeuroSciences)
CODMAN Disposable Perforator 9mm. Cranial Perforator.
| Date | Nov 3, 2025 (initiated Sep 26, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 Acknowledge |
| Quantity | 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, Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183581 | Codman Disposable Perforators Integra Lifesciences Corp., Jan 20, 2019 |