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Tag: recall

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Need to Know Spine Trauma

Spine/Trauma 3D Navigation Software Recall

April 16, 2019 OrthoBuzz

Brainlab AG is recalling its Spine & Trauma 3D Navigation software (version 1.0). The FDA has identified this as a Class I recall, the agency’s

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Need to Know

Lots of Ortho Device Recalls with 510(k) Process

March 31, 2016 OrthoBuzz

Most orthopaedic devices are cleared through the FDA’s 510(k) process. But an analysis in the March 16, 2016 JBJS by Day et al. revealed that

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