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

FDA device recall Z-0810-2013 · posted 2013-02-13 · Terminated

Recall details

Recalling firm

Mizuho OSI

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.

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. .

Root cause

Process control

Status

Terminated

Product code

JEA

Quantity 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, N

Date initiated

2012-12-17

Date posted

2013-02-13

Date terminated

2016-04-15

Location

Union City, CA