PlainRecalls
FDA Devices Moderate Class II Terminated

Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.

Reported: February 20, 2013 Initiated: December 17, 2012 #Z-0810-2013

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.

Details

Recalling Firm
Mizuho OSI
Units Affected
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.
Location
Union City, CA

Frequently Asked Questions

What product was recalled?
Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.. Recalled by Mizuho OSI. Units affected: 869 devices.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0810-2013.