FDA-Device2013-02-20Class II
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Mizuho OSI
Hazard
Possible instability of Orthopedic Table Top. If the epoxy bond fails, the aluminum plug may migrate out of the carbon fiber tube. If this occurs, the Orthopedic Table Spar may need to be replaced to ensure stability of the Orthopedic Table Top.
Sold states
USA Distribution -- Worldwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV and WY., and the countries of Australia, Canada, Egypt, Finland, France, Germany, China, Israel, Italy, Japan, Netherlands, New Zealand, P.R. China, Saudi Arabia, Singapore, Slovenia, South Korea, Spain, Taiwan R.O.C., UAE and UK.
Affected count
869 devices
Manufactured in
30031 Ahern Ave, Union City, CA, United States
Products
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0810-2013Don't want to check this manually?
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