Events

Recall of Device Recall Symmetry Surgical ULTRA(R) Steam container

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Symmetry Surgical, 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
    75850
  • Event Risk Class
    Class 2
  • Event Number
    Z-1010-2017
  • Event Initiated Date
    2016-11-29
  • Event Date Posted
    2017-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151452
  • 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
    Sterilization wrap containers, trays, cassettes & other accessories - Product Code KCT
  • Reason
    Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.
  • Action
    Siemens sent a Customer Safety Notice letter to customers. The letter identified the affected product problem and actions to be taken. Siemens Customer Service Engineer will contact customers to setup an appointment for installation of the new residual current monitor (RCM).

Device

Device Recall Symmetry Surgical ULTRA(R) Steam container
  • Model / Serial
    All
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution
  • Product Description
    symmetry surgical ULTRA(R) Steam container, REF numbers: C131310, C13134, C13135, C13136, C13139, C13854, C13855, C13856, C181310, C18134, C18135, C18136, C18138, C22854, C22855, C22856, C22858, C24134, C24135, C24136 || Product Usage: || sterilization container
  • Manufacturer
    Symmetry Surgical, Inc.

Manufacturer

Symmetry Surgical, Inc.