The FDA is amplifying an effort underway at medical device distributor Medline that aims to correct certain neurosurgery kits containing hardware that may cause bone drills to break apart during a craniotomy procedure.
Previously, Integra LifeSciences launched a recall of some of its Codman disposable perforators due to an inadequate weld on the outer sleeve of the device. The company said the manufacturing defect may cause the 14mm perforator to disassemble, and, in some cases, prevent the device from automatically disengaging and stopping the drill’s rotation as designed.
Earlier this month, the FDA said there have been 10 reported injuries but no deaths related to the issue—including complications from loose device fragments, plus skull and brain injuries, as well as the dangers in delaying the medical procedure itself.
Integra’s Class I recall, first initiated in mid-April, spans more than 170,000 units. The company has directed healthcare providers to quarantine the affected products and return them for credit.
The FDA said some of those recalled Codman perforators may have found their way into about 1,850 craniotomy kits from Medline, which also notified U.S. customers of the issue in April.
This week, the agency spotlighted the distributor’s efforts to reach healthcare providers, which urged them to check their stock and affix warning labels that tell clinicians to remove the 14mm perforators before using the remainder of the kit.