Events

Recall of Device Recall Radiesse

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merz North America, 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
    74252
  • Event Risk Class
    Class 2
  • Event Number
    Z-2607-2016
  • Event Initiated Date
    2016-05-20
  • Event Date Posted
    2016-08-19
  • 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=146973
  • 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
    Implant, Dermal, For Aesthetic Use - Product Code LMH
  • Reason
    Complaints reported of radiesse (+) unable to be expelled from the syringe and/or needle.
  • Action
    Merz sent an Urgent Medical Device Recall Letter dated May 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the enclosed response form and return via fax to (262) 835-3330 or email to complaints2@merz.com. For questions contact Merz at (262) 835-3300 ext. 2627.

Device

Device Recall Radiesse
  • Model / Serial
    Model number: 8063M0K1, Lot #100088744.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states of AR, CA, CO, CT, DC, FL, GA, IL, IN, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, TN, TX, UT, VA, VT and WA.
  • Product Description
    Radiesse (+) Lidocaine, Injectable Implant 1.5cc, Rx only, P/N: 8063M0K1, Merz Aesthetics. || Product Usage: || RADIESSE is indicated for sub-dermal implantation for the correction of moderate to severe facial wrinkles and folds.
  • Manufacturer
    Merz North America, Inc.

Manufacturer

Merz North America, Inc.
  • Manufacturer Address
    Merz North America, Inc., 6501 Six Forks Rd, Raleigh NC 27615-6515
  • Manufacturer Parent Company (2017)
    Merz Holding Gmbh & Co. Kg
  • Source
    USFDA