FDAFDA · Food and drugs·Recall number Z-0810-2013
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Published February 20, 2013 · Recall initiated: December 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mizuho OSI
- Distributor
- 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.
- Lot
- Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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