CODMAN Disposable Perforator, 14mm. Cranial perforator.
Recall
- Recall Number
- Z-1716-2025
- Event Number
- 96694
- Firm
- Integra LifeSciences Corp. (NeuroSciences)
- FEI Number
- 3003418325
- Product Code
- HBF
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- April 11, 2025
- Posted
- May 6, 2025
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650
Description
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Inadequate weld that can potentially cause the product to disassemble.
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 [email protected] 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 [email protected].
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, Ireland, Israel, Italy, Japan, Jordan, Kenya, Korea (the Republic of), Lebanon, Lithuania, Malaysia, Morocco, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom.
170,510 units