Medical device manufacturer Integra has issued a recall for their cranial drills due to a defect linked to ten reported injuries.
Published on Nov. 5, 2024
Integra Lifesciences, a leading medical device company, has initiated a recall of its Codman Disposable Perforators following the discovery of a manufacturing defect. The recall affects over 170,000 units of these devices, used by physicians to drill access holes in skulls during craniotomy procedures.
The primary issue with the Codman Disposable Perforators is an inadequate ultrasonic weld on the outer sleeve, which can cause the device to disassemble during or after use. This disassembly can lead to serious health risks, including brain injury, hemorrhage, prolonged surgery, dural injury, and even death, although no fatalities have been reported thus far.
To address these issues, healthcare providers have been instructed to quarantine and return the affected products. Medline, a distributor of craniotomy kits that include these perforators, has also issued corrections to ensure that the faulty devices are removed from use. Despite these efforts, there have been 10 reported injuries linked to the use of these devices.
The recall was initiated because the drills may break apart during use, potentially causing the device to become lodged in the patient's skull or injure the brain. The Food and Drug Administration (FDA) sent a warning letter to three facilities about the issue months prior to the recall. The FDA has entered five Class I recall entries in its database related to the defect.
Integra Lifesciences identified additional ship holds for certain products, increasing the full-year ship hold forecast to between $55 million and $70 million. These ship holds affect products produced by Integra's Codman and tissue businesses, and three additional recall entries cover Medline Industries' recalls of craniotomy kits that contain the cranial perforator.
In February, Lea Knight, CFO at Integra, revealed on an earnings call that the company had identified $27 million in ship holds related to its compliance plan. Mojdeh Poul, CEO of Integra, stated on an earnings call in May that the company was on track to finish implementing actions outlined in the FDA warning letter by the end of the year. Mojdeh Poul became the CEO of Integra Lifesciences earlier this year.
This recall is not the first time Integra Lifesciences has faced issues with the FDA. Last year, the company received Form 483s from the FDA due to noncompliance with quality system regulations, and the ship holds are related to Integra's quality problems.
[1] Integra Lifesciences Recalls Cranial Drills Due to Manufacturing Defect. (2024, November 5). Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/integra-lifesciences-recalls-cranial-drills-due-manufacturing-defect [2] Integra Lifesciences Announces Recall of Codman Disposable Perforators. (2024, November 5). Retrieved from https://www.integra-ls.com/news/press-releases/integra-lifesciences-announces-recall-of-codman-disposable-perforators [3] Medline Industries Issues Correction Notice for Craniotomy Kits. (2024, November 5). Retrieved from https://www.medline.com/news/press-releases/medline-industries-issues-correction-notice-for-craniotomy-kits [4] FDA Recall Database. (2024). Retrieved from https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-recall-database
- Following a manufacturing defect discovery, Integra Lifesciences, a prominent medtech company, initiated a recall on over 170,000 units of its Codman Disposable Perforators, used in craniotomy procedures.
- The recall was prompted due to an inadequate ultrasonic weld on the outer sleeve of the Codman Disposable Perforators, potentially causing the device to disassemble during or after use.
- Healthcare providers have been instructed to quarantine and return the affected products, with Medline, a craniotomy kit distributor, issuing corrections to remove the faulty devices from use.
- The FDA sent a warning letter to three facilities regarding the issue months prior to the recall, and five Class I recall entries have been made in the FDA's database.
- Integra Lifesciences identified additional ship holds for certain products, increasing the full-year ship hold forecast to between $55 million and $70 million, affecting products from Integra's Codman and tissue businesses.
- In response to the recall, AI-powered analytics in the health-and-wellness sector have been employed to monitor and predict the potential impact on patient safety, medical-conditions, and therapies-and-treatments.
- Despite the recall, news of the incident has sparked discussions on the pressing need for robust regulation in the medtech industry, emphasizing the importance of patient safety and scientific integrity.
