Lucero Medical continues to draw scrutiny from the Food and Drug Administration (FDA) for its spinal fusion device Enduramesh.
The FDA sent a warning letter to Lucero late last month warning the company about documentation and quality-control issues with its medical device. The letter names eight violations found during inspections of Lucero’s facility in Hinckley, Ohio. The violations include failures to maintain device history and to establish procedures for complaints and design control.
A warning letter is considered an advisory and doesn’t mean that the agency intends to take a punitive action against a company.
The letter also notes the Enduramesh is misbranded because it is different from the device approved under the FDA’s 510(k) program, according to MedCity News.
The FDA also issued a recall for the device in February.