Z-0810-2013Class II

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

Name: Z-0810-2013 Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar
Creator: Mizuho OSI
Published: 2012-12-17
License: https://open.fda.gov/license/

Mizuho Orthopedic Systems Inc / initiated 2012-12-17 / Terminated / root cause: manufacturing process

FDA source

Mizuho OSI began a recall of Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar on 2012-12-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0810-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-17
Posted: 2013-02-13
Terminated: 2016-04-15
Recalling firm: Mizuho Orthopedic Systems Inc
Product: Mizuho Orthopedic Table, model 5855, sub assembly 5855-901 Orthopedic Table Spar.
Product code: JEA Table, Surgical With Orthopedic Accessories, Ac-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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. .
Quantity in commerce: 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.
Product codes and lots: Table model 5855, sub assembly 5855-901 Orthopedic Table Spar, manufactured between 1996 and 2007.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0810-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0810-2013	Class II	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-13

Product code JEA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)