Recalls / —

—#213417

Product

CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.

FDA product code: HBF — Drills, Burrs, Trephines & Accessories (Compound, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K073336
Affected lot / code info: Model No. 261230; UDI: 10381780513629; Lot No. Lot Number, 5984530, 7062002, 7062006, 7062013, 7062014, 7255930, 7255931, 7255932, 7255933, 7255934, 7255935, 7255936, 7255937, 7269522, 7269523, 7269524, 7269525, 7282944, 7282945, 7282946, 7282948, 7282949, 7282950, 7282951, 7282952, 7282953, 7293408, 7293409, 7293410, 7293411, 7293412, 7293413, 7293414, 7322892, 7322893, 7322894, 7322895, 7322896, 7322897, 7322898, 7332664, 7332665, 7332666, 7332667, 7332668, 7348744, 7348745, 7348746, 7348747, 7348748, 7371080, 7371081, 7379573, 7379576, 7379577, 7379578.

Why it was recalled

Inadequate weld that can potentially cause the product to disassemble.

Root cause (FDA determination)

Process control

Action the firm took

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 FCA3@integralife.com 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 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 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.

Timeline

Recall initiated: 2025-04-11
Posted by FDA: 2025-05-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #213417. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.