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Extended Tip Applicator recallZ-1959-2025 · Integra LifeSciences Corp. (NeuroSciences) · initiated May 22, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Integra LifeSciences Corp. (NeuroSciences) or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assurance.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1959-2025
Status
Open, Classified
Initiated by the company
May 22, 2025
Posted by the FDA
Jun 20, 2025
Recalling firm
Integra LifeSciences Corp. (NeuroSciences)
Quantity
2,524 units
Product code
FMF
FDA submissions
K091315
Distribution
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.

Product description

Extended Tip Applicator, 15 CM, Box of 5.

Code information (models, lots, serial numbers)

Model/Catalog Number: 205115; UDI: 10381780000150; All Lots.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

2 devices cleared under K091315 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 96934).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page