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Recall Observatory FDA recall evidence

Device product

Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

Z-0810-2013

December 17, 2012

Class II

Product summary

Firm
Mizuho OSI
Event
Event 63991
Status
Terminated
Classification
Class II
Quantity
869 devices
Official record key
device-enforcement:Z-0810-2013

Official wording

Reason: 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.

Code information: Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.