FDAClass IIMay 31, 2023

Codman Cranial Hand Drill- Indicated when a craniotomy recall

Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or…

Why was Codman Cranial Hand Drill- Indicated when a craniotomy 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: 10381780520337 Lot Numbers: 6808685, 6563961, 6568711, 6568709, 6568710

Product
Codman Cranial Hand Drill- Indicated when a craniotomy is required for placement of an intracranial pressure (ICP) monitoring device and/or…
Recalling firm
Integra LifeSciences Corp.
Quantity
337 units
Distribution
PA Foreign: Australia, Belgium
Recall date
May 31, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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