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Recall Observatory FDA recall evidence

Device product

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

Z-1717-2025

April 11, 2025

Class I

Product summary

Firm
Integra LifeSciences Corp. (NeuroSciences)
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

    reason.no_named_rule · v1.0.0

    Inadequate weld that can potentially cause the product to disassemble.