Cranial Hand Drill recalled due to rust on chuck components
Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill due to rust contamination on the drill chuck. The rust may cause inflammation, infection, and complications requiring revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. This is a risk-of-harm product—a surgical instrument contaminated with rust that poses potential for inflammation, infection, and surgical complications—where injury has not yet been reported.
Plain-English summary
Integra LifeSciences Corp. is recalling 337 units of the Codman Cranial Hand Drill (part number 82-6607), a surgical device used during craniotomy procedures to create openings in the skull for intracranial pressure monitoring or cerebrospinal fluid drainage. The device has been classified as a Class II recall.
The affected units have rust or discoloration on the drill chuck and inner chuck. This contamination presents a risk of inflammation, local toxicity, systemic toxicity, allergic sensitivity, and infection at the surgical site. These complications could potentially require revision surgery and cause procedural delays.
The affected devices were distributed to medical facilities in Pennsylvania and internationally to Australia and Belgium. The recalled lot numbers are 6808685, 6563961, 6568711, 6568709, and 6568710. Healthcare facilities should immediately discontinue use of these devices and contact Integra LifeSciences Corp. for replacement or return instructions.
The recalled product
- Product
- 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
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Surgical Drill
- Affected units
- 337
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- UDI-DI: 10381780520337 Lot Numbers: 6808685
- 6563961
- 6568711
- 6568709
- 6568710
Distribution
Distributed in 1 state:
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