CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
Reported: May 14, 2025 Initiated: April 11, 2025 #Z-1717-2025
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.
Details
- Recalling Firm
- Integra LifeSciences Corp. (NeuroSciences)
- Units Affected
- 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.
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.. Recalled by Integra LifeSciences Corp. (NeuroSciences). Units affected: 1,840 units.
Why was this product recalled? ▼
Inadequate weld that can potentially cause the product to disassemble.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 14, 2025. Severity: Critical. Recall number: Z-1717-2025.
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