FDA-Device2025-05-14Class I
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Integra LifeSciences Corp. (NeuroSciences)
Hazard
Inadequate weld that can potentially cause the product to disassemble.
Sold states
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.
Affected count
1,840 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1717-2025Don't want to check this manually?
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