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Mako Surgical Corporation recalls MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Recalled March 15, 2017 · FDA recall Z-1411-2017 · Mako Surgical
Hazard
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides · FDA Class II
Units
777
Sold at
US nationwide distribution.
Description
Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
Product
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →