Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
FDA Recall #Z-0810-2013 — Class II — December 17, 2012
Product Description
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Reason for Recall
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.
Recalling Firm
Mizuho OSI — Union City, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
869 devices
Distribution
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.
Code Information
Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated