Recall Z-0810-2013
Mizuho OSI · initiated December 17, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Codes / lots: Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.
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.
FDA-determined 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. .
Details
- Recall number
- Z-0810-2013
- Initiated
- December 17, 2012
- Posted by FDA
- February 13, 2013
- Terminated
- April 15, 2016
- Product code
- JEA – Table, Surgical With Orthopedic Accessories, Ac-Powered
- 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.…
- Recalling firm
- Mizuho OSI, Union City, CA