Extended Tip Applicator, 15 CM, Box of 5.
Recall
- Recall Number
- Z-1959-2025
- Event Number
- 96934
- Firm
- Integra LifeSciences Corp. (NeuroSciences)
- FEI Number
- 3003418325
- Product Code
- FMF
- Status
- Open, Classified
- Root Cause
- Process change control
- Initiated
- May 22, 2025
- Posted
- June 20, 2025
- Address
- 1100 Campus Rd, Princeton, NJ, 08540-6650
Description
Extended Tip Applicator, 15 CM, Box of 5.
Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.
An URGENT: VOLUNTARY MEDICAL DEVICE RECALL notification dated 5/22/25 was mailed to consignees for this product removal. Consignees are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at [email protected] or by FAX at 1-609-750-4220. The provided notification is to be forwarded to users of affected devices and a copy retained for consignee records. A Return Material Authorization number will be generated upon receipt of the Acknowledgment Form for credit. Sales Representatives and Distributors are instructed to inspect their inventory for affected devices and quarantine any identified. The provided Acknowledgement form is to be completed and returned to Integra by email at [email protected] or by FAX at 1-609-750-4220. Distributors who further distributed affected devices are to forward the provided notification to their customers and collect Acknowledgement forms on their behalf to submit to Integra. Sales Representatives will be contacted by Post Market Quality to coordinate return of devices. Consignees with any questions are to contact Customer Service by phone at 1-800-654-2873 or by email at [email protected]. Additional communications were made to customers on 7/10/25 and 7/18/25 informing them that expired devices are also subject to this recall and should be disposed of.
Domestic: Nationwide Distribution; Foreign: Canada, Japan, Australia, New Zealand, Taiwan (Province of China), Mexico, Colombia, Dominican Republic (the), Singapore, Mongolia, Hong Kong, Chile, Argentina, Puerto Rico, El Salvador, Guatemala, Korea (the Republic of), Peru, Costa Rica, Panama, From Belgium, distributed to: Austria, Belgium, Cyprus, Czechia, France, Georgia, Germany, Greece, Hungary, Iran (Islamic Republic of), Ireland, Italy, Jordan, Malta, Netherlands (the), Nigeria, Palestine, State of, Portugal, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey.
2,524 units