The U.S. Food and Drug Administration (FDA) recently issued a warning letter to Globus Medical, Inc. related to an inspection on February 15, 2024, through March 7, 2024.
FDA Warning Letter to Globus Medical
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The warning letter pertained to the “Class II Excelsius GPS surgical robot and associated interbody spine and cranial modules.” According to the warning letter, the inspection revealed that the devices are adulterated in that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements.”
Wells Fargo Securities, LLC (Wells Fargo) issued a report after its FDA consultant reviewed the warning letter. The consultant’s assessment of the warning letter is that “it does not raise material concerns regarding the operation of the company at this point.” According to the consultant, the issues raised in the warning letter are “fairly ordinary.”
The warning letter also indicated three violations under the Medical Device Reporting (MDR) regulation. The Wells Fargo consultant noted that the “most notable aspect” of the warning letter is that Globus Medical is “cited for not having maintained electronic acknowledgements from FDA of the MDRs.” The Wells Fargo consultant indicated that maintaining copies of electric acknowledgements is a “relatively new” requirement for companies.
Globus Medical has provided a number of responses to the warnings. Initially, Globus Medical SVP of Quality Assurance and Information Technology Daniel S. Paul provided two responses within a few weeks of the inspection. The responses were, per the warning letter, concerning the investigators’ observations. The responses were also addressed in the warning letter.
At this time, a response letter is not available on the FDA website. However, according to a flash comment by Wells Fargo analysts on the matter, Globus Medical has “already filed a formal response with the FDA that included more data/formal documentation to address the FDA’s concerns.” —
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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