Events

Recall of Device Recall OPERON Hand Controls for Operon D750, D752, D760, D820 and D850

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
    65062
  • Event Risk Class
    Class 2
  • Event Number
    Z-1488-2013
  • Event Initiated Date
    2013-03-12
  • Event Date Posted
    2013-06-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117821
  • 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
    Table, operating-room, electrical - Product Code GDC
  • Reason
    The firm received complaints for unintended movements.
  • Action
    Berchtold sent an Urgent Medical Device Recall letter in March 2013, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were recommended to clean the affected product and use the instructions to reduce the possibility of unintended movements until the firm could replace the affected product. Customers with questions were advised to contact the Berchtold Operon Pendanct Recall Coordinator at 800-243-5135, or 843-569-6100, ext 306. For questions regarding this recall call 843-569-6133.

Device

Device Recall OPERON Hand Controls for Operon D750, D752, D760, D820 and D850
  • Model / Serial
    The hand controls are neither serialized nor lot coded.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Hand Controls for Operon D750, D752, D760, D820 and D850 || The hand controls are used to operate OPERON surgical tables
  • 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