Device product
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Z-1717-2025
Product summary
- Event
- Event 96694
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1,840 units
- Official record key
device-enforcement:Z-1717-2025
Official wording
Reason: Inadequate weld that can potentially cause the product to disassemble.
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.
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.
Derived failure modes
-
Unknown
Inadequate weld that can potentially cause the product to disassemble.