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Synthes gets FDA warning on bone void filler use

This article was originally published in Clinica

Executive Summary

Synthes has received an FDA warning letter for allegedly promoting two orthopaedic products for unapproved spinal application. The two products in question - the Norian XR Calcium Phosphate Bone Void filler and Norian SRS Bone Void Filler - are not intended to treat vertebral compression fractures, such as are common in patients with osteoarthritis because it is not known whether the products might cause an embolism, the FDA notes.

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