Hinckley, Ohio-based Lucero produces a cylindrical-shaped, titanium mesh device that’s implanted in the spine to replace collapsed or diseased vertebrae. The device, called the Enduramesh, is designed to aid in spinal fusion.
The warning letter specified eight violations uncovered during inspections of Lucero’s facilities. The violations range from failure to establish procedures for the handling of complaints to failure to maintain device history records to failure to implement design control procedures.
Lucero president Michael Conrad didn’t return a call.
Warning letters are considered by the FDA to be informal and advisory, and don’t necessarily indicate that the FDA intends to take any punitive action against recipients.
The letter also noted that the Enduramesh device was misbranded because it differs from the device that was cleared under the FDA’s 510(k) program.
Much of the information related to the differences between the two devices was redacted, so details on specifics are hard to come by. “A change from a single-use only device to a [redacted] device constitutes a major change or modification in the intended use of the device and therefore requires a new 510(k),” the letter states.
A recall was placed on the Enduramesh device in February, according to a notice on the FDA’s website.