—#216126

Product

CODMAN Disposable Perforator 9mm. Cranial Perforator.

FDA product code: HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K183581
Affected lot / code info: Model No. 261223; UDI: 10381780513605; Lot No. 5828553, 6264478, 6264481, 6264482, 7230672, 7230673, 7230674, 7230675, 7261971, 7268008, 7268009, 7268010, 7268011, 7268012, 7268013, 7268014, 7268015, 7268016, 7268017, 7268018, 7268019, 7282954, 7282955, 7293422, 7293423, 7293424, 7293425, 7293426, 7293427, 7293428, 7300667, 7300668, 7300669, 7300670, 7300672, 7300673, 7300674, 7371082, 7371083, 7379652, 7379922, 7379923, 7379924, 7379926, 7379928, 7379660, 7379925, 7379927, 7450559, 7450560, 7450561, 7450562, 7450563, 7450564, 7450565, 7450566, 7451273, 7451274, 7451275, 7451276, 7451277, 7451278, 7451279; Expiration Date: 2024-03-31 to 2029-07-31.

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Integra LifeSciences Corp. (NeuroSciences)
Address: 1100 Campus Rd, Princeton, New Jersey 08540-6650

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-09-26
Posted by FDA: 2025-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #216126. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.