Events

Recall of Device Recall BUDDE Halo Neurosurgical Retractor System, Model 40A1040.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ohio Medical Instrument Co 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
    25715
  • Event Risk Class
    Class 2
  • Event Number
    Z-0781-03
  • Event Initiated Date
    2003-02-26
  • Event Date Posted
    2003-04-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=26349
  • 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
    Retractor, Self-Retaining, For Neurosurgery - Product Code GZT
  • Reason
    The component was manufactured with an insufficient weld that could break during use.
  • Action
    The firm contacted their accounts by email and telephone on 2/26/2003.

Device

Device Recall BUDDE Halo Neurosurgical Retractor System, Model 40A1040.
  • Model / Serial
    Lot # 031 - etched on the side of the Clamp Assembly
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were shipped to domestic consignees in NY, NJ, IL, and FL; and to foreign customers located in Japan, Hong Kong, Korea, Great Britian, and Germany.
  • Product Description
    Halo Support Bracket Assembly (Part #438-B1010). The bracket is sold as a component of the BUDDE Halo Neurosurgical Retractor System, or sold as a separate component. The defective sub-assembly part is the Clamp Assembly (Part #438A1071), which is part of the Halo Bracket Assembly.
  • Manufacturer
    Ohio Medical Instrument Co Inc

Manufacturer

Ohio Medical Instrument Co Inc
  • Manufacturer Address
    Ohio Medical Instrument Co Inc, 4900 Charlemar Dr, Cincinnati OH 45227
  • Source
    USFDA