Z-0810-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 20, 2013
- Initiation Date
- December 17, 2012
- Termination Date
- April 15, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 869 devices
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.
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.
Code Information
Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.