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FDA says MAKO recalled RIO software, sent notice in August

The FDA said on its website yesterday that MAKO Surgical recalled its RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported, the agency said. Mako Surgical sent an Important Medical Device Correction letter dated August 31, 2012, to all affected customers, the FDA added.