Events

Recall of Device Recall ProFx 6850

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Mizuho Orthopedic Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56859
  • Event Risk Class
    Class 2
  • Event Number
    Z-0924-2011
  • Event Initiated Date
    2010-03-30
  • Event Date Posted
    2011-01-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94677
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ac-Powered Surgical Table with Orthopedic Accessories - Product Code JEA
  • Reason
    Device component spar gear box locks up and may result in failure of push pull tube, which may result in release of breaking and impact.
  • Action
    All customers will be contacted to arrange for removal and shipping arrangements. Verification will be done by the Repair and Verification instructions for the leg spars, via registered letters. *******UPDATED INFO---The firm sent another notification letter---dated 12/22/10---which states in part: "****The upgrade involves the correction of your 6850 PROfx¿ spars (6850-2100) at your facility by a Qualified Technician. The spars shall be upgraded to remove the 6850-2123, Drive Bracket, Spar Push Rod and replace it with the 6850-2170, Drive Bracket, Spar Push Rod. Upon completion of the upgrade, the 6850-2123, Drive Bracket, Spar Push rod shall be returned to Mizuho OSI for processing.*******

Device

Device Recall ProFx 6850
  • Model / Serial
    all units.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA & Germany.
  • Product Description
    Mizuho ProFx 6850 Operating Room Table, with orthopedic accessories, AC Powered, manufactured by Mizuho OSI, Union City, CA.
  • Manufacturer
    Mizuho Orthopedic Systems Inc

Manufacturer

Mizuho Orthopedic Systems Inc
  • Manufacturer Address
    Mizuho Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587
  • Manufacturer Parent Company (2017)
    Mizuho Co. Ltd.
  • Source
    USFDA