FDA-Device2023-05-31Class II
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
Integra LifeSciences Corp.
Hazard
Released with discoloration (rust) on the Drill Chuck and inner chuck of Codman Cranial Hand Drill may result in inflammation, local toxicity, systemic toxicity, sensitivity, revision surgery, procedural delay, inconvenience to user, and/or infection.
Sold states
PA Foreign: Australia, Belgium
Affected count
337 units
Manufactured in
1100 Campus Rd, N/A, Princeton, NJ, United States
Products
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or cerebrospinal fluid drainage device. Part Number: 82-6607
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1614-2023Don't want to check this manually?
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