FDA issues recall on defective cranial drills after 10 injuries
The U.S. Food and Drug Administration (FDA) announced a recall on craniotomy drills manufactured by Integra LifeSciences, due to a dangerous manufacturing issue that could cause severe injuries or possibly kill patients.
A line of Codman Disposable Perforators and Craniotomy Kits has an inadequate ultrasonic weld that could cause drills to become dislodged in a patient’s skull. The kits are used to enter the cranium during a wide variety of sensitive procedures, including brain surgery.
To date, 10 injuries have been reported, in incidents ranging from delayed care to bleeding and cerebral injury. Due to the major safety risks associated with the devices, they are to be pulled from all surgery settings and supply houses immediately.
What is being recalled?
Two product lines from Integra contain the disposable drills subject to this recall:
Name: Codman Disposable Perforator 14 mm
Unique Device Identifier (UDI): 10381780513599
Name: Codman Craniotomy Kit Containing Disposable Perforator 14 mm, Cranio-blade, Wire Pass Drill
UDI: 10381780513629
Next steps
Providers must stop using the affected products immediately. The devices must be quarantined to keep patients safe.
Integra sent all known customers a letter in April alerting them to the defect, asking that inventory be reviewed to locate all the dangerous drills. A form was included to initiate a return for credit.
Those with questions can contact the company at [email protected] or 1-800-654-2873.
Integra and the FDA also request that the recall notice be shared to spread awareness. It can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.