Reported May 31, 2023 · Ongoing
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP)…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 1100 Campus Rd · Princeton, NJ · 08540-6650
Is this the product you have?
- 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 Number82-6607
- Lot codes and dates
- UDI-DI10381780520337
- Lot Numbers
68086856563961656871165687096568710
- Amount recalled
- 337 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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