Events

Recall of Device Recall Doro Adapter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    37510
  • Event Risk Class
    Class 2
  • Event Number
    Z-0780-2007
  • Event Initiated Date
    2007-02-14
  • Event Date Posted
    2007-05-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50689
  • 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
    surgical table patient support - Product Code FWZ
  • Reason
    Material used to manufacture accessory bracket does not meet product specification. the screw is normally composed of ''torlon'', which is yellow. the part was made of "tercite", which is blue.
  • Action
    A notification letter was sent to all 8 consignees on 02/16/2007. The firm will send service representatives to review any devices on site and replace with the proper part if needed.

Device

Device Recall Doro Adapter
  • Model / Serial
    Product Number 5979-300, listing 878.4950.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The products were distributed to 8 consignees in the United States, to ID, IL, NY, and CA.
  • Product Description
    Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to support patients during spinal surgery.
  • Manufacturer
    Orthopedic Systems Inc

Manufacturer

Orthopedic Systems Inc
  • Manufacturer Address
    Orthopedic Systems Inc, 30031 Ahern Ave, Union City CA 94587-1234
  • Source
    USFDA