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www.fdanews.com/articles/145735-maker-of-spine-replacement-systems-warned-for-procedural-shortcomings

Maker of Spine Replacement Systems Warned for Procedural Shortcomings

April 19, 2012
Lucero Medical, an Ohio-based maker of vertebral body replacement devices, has been warned for lacking a slew of basic manufacturing procedures and for various 510(k) clearance violations. Lucero makes a product called Enduramesh, an implantable spinal vertebral replacement device available in multiple lengths and diameters and which come with complimentary mesh trimmers.
The GMP Letter