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S&N Class I recall

This article was originally published in The Gray Sheet

Executive Summary

FDA applies a Class I designation to Smith & Nephew's recall of 539 radiofrequency denervation probes on March 26. The firm began recalling the probes in January because they were mislabeled as sterile, which could lead to infections with associated risks of "organ failure and/or death," according to FDA. The probes are used with Smith & Nephew's Electrothermal 20S spine system in RF lesion procedures to relieve chronic pain. No injuries have been reported, according to the firm. Smith & Nephew is providing replacements to its 134 U.S. and international customers...

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