Events

Recall of Device Recall The Cellfina System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ulthera 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
    75682
  • Event Risk Class
    Class 2
  • Event Number
    Z-0749-2017
  • Event Initiated Date
    2016-11-14
  • Event Date Posted
    2016-12-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151050
  • 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
    Powered surgical instrument for improvement in the appearance of cellulite - Product Code OUP
  • Reason
    It was discovered that a non-sterile vacuum tube is supplied within the pack, although the instructions for use (ifu) describe the use of a sterile vacuum tube as part of the procedure setup.
  • Action
    Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at mymerzsolutions@merz.com.

Device

Device Recall The Cellfina System
  • Model / Serial
    all
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
  • Product Description
    Cellfina Prep Pack, Part No. CP1
  • Manufacturer
    Ulthera Inc

Manufacturer

Ulthera Inc
  • Manufacturer Address
    Ulthera Inc, 1840 S Stapley Dr Ste 200, Mesa AZ 85204-6681
  • Manufacturer Parent Company (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA