CODMAN Disposable Perforator 9mm. Cranial Perforator.

FDA device recall Z-0374-2026 · posted 2025-11-03 · Open, Classified

Recall details

Recalling firm

Integra LifeSciences Corp. (NeuroSciences)

Reason for recall

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.

Action taken

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 Acknowledgement Form to FCA3@integralife.com 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 custsvcnj@integralife.com.

Root cause

Process change control

Status

Open, Classified

Product code

HBF

Quantity affected

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,

Date initiated

2025-09-26

Date posted

2025-11-03

Location

Princeton, NJ

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