Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
- Company
- Mizuho Osi
- Recall Initiated
- December 17, 2012
- Posted
- February 13, 2013
- Terminated
- April 15, 2016
- Recall Number
- Z-0810-2013
- Quantity
- 869 devices
- Firm Location
- Union City, CA
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
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 / Code Info
Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
Root Cause
Process control
Action Taken
Mizuho sent a Recall Notification letter dated December 28, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The Orthopedic Table Spar will be replaced at no cost by Mizuho technicians. Customers were informed the potential failure and were advised inspection of tables prior to use. If tables are experiencing the described failure, contact Mizuho Resource Group at 1-800-777-4674, option 2. .