Events

Recall of Device Recall OT1000 Series Orthopedic Surgical Tables

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

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
    74264
  • Event Risk Class
    Class 2
  • Event Number
    Z-2248-2016
  • Event Initiated Date
    2016-05-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147015
  • 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, ac-powered - Product Code JEA
  • Reason
    Steris has identified that the pivot pin assembly located on the table top may become loose preventing the table from articulating properly.
  • Action
    Recall Notification Letters to the affected Consignees was sent on May 23, 2016 via FedEx with tracking numbers for delivery confirmation. STERIS Field Service Technicians will visit each domestic Customer location to perform the inspection and reinstallation of the pivot pin assemblies. For international direct accounts who have further distributed the surgical table, Steris asked to identify the Customers, and to notify them of this product field correction, and that not to operate the tables until the inspection has been done of the pivot pin assembly on all affected tables.

Device

Device Recall OT1000 Series Orthopedic Surgical Tables
  • Model / Serial
    OT1000, OT1100, and OT1200 Orthopedic Surgical Table
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    AL;AK, AZ; AR; CA; CO; CT; DC; FL; GA; IL; IN; IA; NY; NJ; NC; OH; OK; OR; PA; PR; SC; TX; UT and VA. Foreign accounts: Canada; France; Korea; Panama; Qatar and Thailand.
  • Product Description
    OT1000 Series Orthopedic Surgical Tables
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • Manufacturer Address
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • Manufacturer Parent Company (2017)
    Steris Corporation
  • Source
    USFDA