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  • JL Tox Consulting

NuVasive MAGEC system components recall highlights importance of Biocompatibility

Updated: Sep 4, 2023

One of the most unique aspects of medical device #biocompatibility is just how quickly your work can have a direct impact on patients. The recent issue with the NuVasive MAGEC system components highlights this very well. They issued a recall due to a mechanical failure of some of their products in February 2020. At some point NuVasive performed a #biocompatibility evaluation of that mechanical failure which raised a potential issue. NuVasive issued an updated Field Safety Notice in December 2020 raising the potential #biocompatibility concerns associated with that mechanical failure. The FDA began receiving reports describing local tissue reactions potentially related to the #bicompatibility issues by early 2021. A mere few months between a #biocompatibilty evaluation and an unfortunate clinical result. This is why #biocompatibility is so important!


Additionally, kudos to NuVasive for acting quickly and heading the recommendations of their #toxicologist and #biocompatibilitySME in issuing the updated notice!


#fda#medicaldevices#biocompatibility#toxicology#JLTox


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