Events

Recall of Radiesse () Injectable Implant

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
    72585
  • Event Risk Class
    Class 2
  • Event Number
    Z-0366-2016
  • Event Initiated Date
    2015-10-26
  • Event Date Posted
    2015-12-03
  • 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=141612
  • 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
    The expiration date encoded in the udi barcode on the label on the product carton and the peelable patient identification label is incorrect.
  • Action
    Letters dated 11/4/2015 were sent to customers with tracking and delivery confirmation. The letter informs the customer that they may continue to safely use the affected product by referring to the USE BEFORE date.

Device

Radiesse () Injectable Implant
  • Model / Serial
    Lot No. 100083189
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including the states of AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NH, NJ, NY, NC, OH, OK, PA, SC, TN, TX, UT, VA, WA, and WI.
  • Product Description
    Radiesse (+) Lidocaine Injectable Implant 1.5cc, P/N: 8063M0K1. Indicated for subdermal 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