Cranial Drill Recall: Integra LifeSciences Recalls Codman Disposable Perforators Due to Risk of Device Disassembly
Integra LifeSciences has recalled specific Codman Disposable Perforators because the devices may disassemble during or after a procedure. This mechanical failure poses risks of brain injury, hemorrhage, and increased surgical duration.
This recall affects Integra LifeSciences, neurosurgical departments, hospital sterile processing units, and clinical staff utilizing Codman disposable cranial drills.
The risk of device disassembly during invasive cranial procedures likely categorizes this as a high-risk safety event requiring immediate field correction. For regulatory and quality professionals, this indicates a potential mechanical design or manufacturing assembly failure that necessitates thorough root cause analysis and reconciliation of all distributed units. Failure to mitigate this risk could lead to significant patient morbidity or legal liability.
Immediately identify and sequester all affected Codman Disposable Perforator units within inventory. Quality teams should initiate a retrospective review of surgical reports for any undocumented instances of device disassembly or associated patient injury. Ensure formal documentation of the recall action is maintained for inspection readiness.
Certain Codman Disposable Perforators may disassemble during or after use, increasing the risk of brain injury, hemorrhage, or prolonged surgery.
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