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The company received complaints that distinguishing the smooth from rough surface of the device proved difficult, which could lead to major adverse events. Read More
Orthopedic companies should be allowed to continue distributing devices that don’t bear unique device identifiers even after the FDA’s compliance deadline, Globus Medical says in a recent citizen’s petition to the agency. Read More
Manufacturers of power morcellators are facing mounting woes as patients file product liability lawsuits across the U.S. and at least one major insurance company narrows its coverage of treatments with the device. Read More
Inadequate complaint and CAPA procedures following reports of serious incidents including patient deaths led to a warning letter for a California surgical equipment manufacturer. Read More
Panelists and stakeholders at an FDA advisory panel meeting on infectious outbreaks linked to improperly cleaned endoscopes struggled to find ways to enhance device safety while staying within the limits of FDA authority. Read More