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Spinal Concepts gets FDA warning on BacFix problem

This article was originally published in Clinica

Executive Summary

Failure to keep records about an instrument failure and document how it was fixed has earned Spinal Concepts (Austin, Texas), an FDA warning letter. The company makes the BacFix Thoracolumbar System, the Harmonym PLIF Instrument Set and the Cadence Vue vertebral body replacement device.

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