Events

Recall of Device Recall Operon

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Berchtold Corp..

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
    51276
  • Event Risk Class
    Class 2
  • Event Number
    Z-1123-2009
  • Event Initiated Date
    2009-02-02
  • Event Date Posted
    2009-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=79572
  • 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
    Electrical Operating-Room Table - Product Code GDC
  • Reason
    Difficulty in pressing the button needed to release a bed part resulted in an injury to a caregiver's finger which became stuck in metal latch under the gas cylinder of the bed piece.
  • Action
    An official notification letter dated February 3, 2009 was hand-carried by a local Berchtold Corporation Technical Service representative to each account. The letter indicated that the Berchtold Corporation Service Technician will complete recommended upgrades. Direct questions concerning this recall to your BERCHTOLD Technician Service at 1-800-243-5135 and press the Number 2.

Device

Device Recall Operon
  • Model / Serial
    D 850, D750, D 752 and B 810.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US and Canada.
  • Product Description
    Operon Electrical Operating Room Table. || The device is used as an electrical operating room table.
  • Manufacturer
    Berchtold Corp.

Manufacturer

Berchtold Corp.
  • Manufacturer Address
    Berchtold Corp., 1950 Hanahan Rd, N Charleston SC 29406-4878
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA