Dive Brief:
- Integra Lifesciences has recalled cranial drills over a defect linked to 10 injuries, the Food and Drug Administration said Wednesday.
- The company has asked customers to return Codman cranial perforators because they may break apart during use, causing the device to become lodged in the patient’s skull or injure the brain.
- Integra began the recall months after the FDA sent a warning letter to three facilities that make products including cranial perforators.
Dive Insight:
Physicians use the cranial perforators to drill access holes in skulls. The Codman devices are designed to disengage automatically once drilling is complete. Integra asked customers to quarantine and return affected devices in April after learning that inadequate welds on specific lots could cause the devices to break or separate.
The defect has resulted in problems including a procedural delay, difficulty removing device fragments and bleeding, the FDA said, and some devices fail to disengage and stop immediately. There have been no reports of death.
The FDA entered five Class I recall entries in its recall database in relation to the defect. Two of the entries cover Integra recalls of 170,510 units of its disposable cranial perforator and 1,840 units of a craniotomy kit that contains the affected device. The other three entries cover Medline Industries’ recalls of craniotomy kits that contain the cranial perforator.
Integra received Form 483s last year after the FDA deemed devices including cranial perforators to be noncompliant with quality system regulations. Later in 2024, the FDA sent a warning letter in relation to problems described in the Form 483s.
The company designed a compliance plan to address its quality problems. Lea Knight, CFO at Integra, said on an earnings call in February that the company had identified $27 million in ship holds related to the compliance plan.
Integra identified additional ship holds for certain products at its Codman and tissue businesses late in the first quarter, CEO Mojdeh Poul said on an earnings call in May. The discoveries raised the full-year ship hold forecast to between $55 million and $70 million. Poul said Integra was on track to finish implementing actions outlined in the warning letter by the end of the year.
