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Mako Surgical Corporation recalls Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical compone
Recalled February 22, 2017 · FDA recall Z-1193-2017 · Mako Surgical
Hazard
Failure of the Offset Cup Reamer Handle not engaging its mating components. · FDA Class II
Units
595 units
Sold at
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
Description
Failure of the Offset Cup Reamer Handle not engaging its mating components.
Product
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
Manufacturer(s)
Mako Surgical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →