CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforat...
FDA Recall #Z-1717-2025 — Class I — April 11, 2025
Product Description
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Reason for Recall
Inadequate weld that can potentially cause the product to disassemble.
Recalling Firm
Integra LifeSciences Corp. (NeuroSciences) — Princeton, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
1,840 units
Distribution
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.
Code Information
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated