Events

Recall of Schaerer 7300 surgical table

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Schaerer Medical USA 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
    75288
  • Event Risk Class
    Class 2
  • Event Number
    Z-0371-2017
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149952
  • 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, surgical with orthopedic accessories, manual - Product Code JEB
  • Reason
    The floor locking cylinders contained in the base of the schaerer 7300 model surgical tables were manufactured with the incorrect "o" ring which may cause the cylinder to leak.
  • Action
    Schaerer Medical sent a Field action letters dated September 27, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The customer is required to complete and return a response form with the number of affected tables and cylinders. All affected cylinders will be replaced in the field and returned to the manufacturer. For questions Quality Assurance at 513-272 -9116.

Device

Schaerer 7300 surgical table
  • Model / Serial
    Lot Codes for the four (4) model 7300 Surgical Tables  TFX-1653, TFX1654, TFX1655, TFX1656
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of: CA, CT, FL, IA, IN, MI, MN, MO, OH, PA, and VA Replcement cylinders wre distributed
  • Product Description
    The surgical table is a stand alone unit. Three (3) floor locking cylinders are attached to the base of the surgical table. The individual cylinders are replaceable. || Product Usage: || The cylinders are used to lock the surgical table in place.
  • Manufacturer
    Schaerer Medical USA Inc

Manufacturer

Schaerer Medical USA Inc
  • Manufacturer Address
    Schaerer Medical USA Inc, 675 Wilmer Ave, Cincinnati OH 45226-1802
  • Manufacturer Parent Company (2017)
    Schaerer Medical Usa Inc.
  • Source
    USFDA