CODMAN Disposable Perforator 9mm. Cranial Perforator.
Recall
- Recall Number
- Z-0374-2026
- Event Number
- 97623
- Firm
- Integra LifeSciences Corp. (NeuroSciences)
- FEI Number
- 3003418325
- Product Code
- HBF
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- September 26, 2025
- Posted
- November 3, 2025
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650
Description
CODMAN Disposable Perforator 9mm. Cranial Perforator.
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.
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 [email protected] 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 [email protected] 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 [email protected].
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.
5,109 units