Stryker Corporation announced on March 12, 2013 that its Instruments division has received a warning letter from the FDA related to an FDA site visit made during a November 2012 inspection at its Portage, Michigan, location.
FDA Quality Systems Warning for Stryker
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The letter concerns quality system and cites Stryker for failing to notify the FDA of a product recall, and for marketing devices, including the Neptune Waste Management System, without a required 510(k) clearance. The letter acknowledged that Stryker Instruments has already submitted corrective action plans for the quality system and recall observations.
The Neptune product line and certain hip implant products were part of a series of recalls by Stryker last year. The Neptune recall was classified as the most serious type of recall which involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
The Neptune Waste Management System is intended to collect and dispose of surgical fluid waste in operating rooms and surgical facilities.
The company is fully cooperating with the FDA to resolve these matters in a comprehensive and timely manner.
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Discussion
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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