Cranial Drill Urgent Recall Alert
Serious safety risksUrgent Class I Medical Device Recall
Integra LifeSciences has issued an urgent recall of specific Codman Disposable Perforators and Craniotomy Kits due to a serious manufacturing defect that may lead to device disassembly during neurosurgical procedures. The FDA has classified this as a Class I recall, the most serious type, due to the risk of severe injury or death.
Affected Products
- Codman Disposable Perforator 14 mm – UDI: 10381780513599
- Codman Craniotomy Kit (includes Perforator, Cranio-blade, Wire Pass Drill) – UDI: 10381780513629
Lot/Serial Numbers: Full List of Affected Lots
Reason for Recall
A faulty ultrasonic weld (known as a “proud weld”) on the device’s outer sleeve may cause the perforator to disassemble unexpectedly during use. In some cases, the device fails to disengage properly, putting patients at serious risk for:
- Brain tissue injury
- Bleeding or dural damage
- Extended surgery time
- Irreversible harm or even death
To date, 10 serious injuries have been reported—including devices lodged in the skull and fragments difficult to remove. No fatalities have been reported.
Recommended Actions for Users and Facilities
- Immediately stop using and quarantine all affected products.
- Review inventory against the provided lot numbers.
- Notify surgical and supply staff of the recall.
- Contact Integra for a Return Material Authorization (RMA) and return the product for credit.
Device Function
Codman Disposable Perforators are single-use neurosurgical tools designed to drill precise openings into the skull during craniotomy. They are engineered to disengage automatically after drilling to prevent over-penetration—but this defect undermines that safety feature.
Contact
For questions or to report issues, call Integra LifeSciences at 1-800-654-2873 or email FCA3@integralife.com.
Check the FDA recall web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.
Hospira Recalls Antibiotic for Presence of Glass Particles
Hospira, Inc., a division of Pfizer, announced a Class I recall of its Vancomycin Injection product due to visible glass particles that were identified in one vial of the drug. The recall involves lot 33045BA of Vancomycin Hydrochloride Injection USP 1.5g single dose...
Three Companies Recall Blood Pressure Medication
All recalled products had unacceptable levels of nitrosamines Three pharmaceutical manufacturers have recalled batches of the blood pressure drug quinapril this year for exceeding safe levels of nitrosamines. Luprin Pharmaceuticals, Aurobindo Pharma USA, and Pfizer...
FDA Announces Online Electronic 510(k) Submissions
The U.S. Food and Drug Administration (FDA) announced the issuance of its final guidance document for its template for electronic 510(k) submissions on September 22, 2022. The electronic Submission Template and Resource (eSTAR) electronic submissions template is a...