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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