Events

Recall of Enhancement Medical expression

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

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
    68596
  • Event Risk Class
    Class 1
  • Event Number
    Z-2135-2014
  • Event Initiated Date
    2013-08-07
  • Event Date Posted
    2014-08-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128288
  • 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
    Manufacturer made a change in the production process that resulted in a change in final gel weight. recall expanded 7/8/2014 firm expanded their recall to include all lots of product.
  • Action
    Enhancement Medical, LLC called all Independent Sales Representatives and then provided each representative a list of consignees with impacted product and instructed the Representatives to disclose low gel weight issue and potential for common treatment responses. Representatives were instructed to exchange the affected product. EXPANDED Enhancement Medical sent an Urgent Medical Device Recall letter beginning July 8, 2014 to all consignees whom received product. The letter identified all lots as being recalled, the reason for the recall, recommended that Expression not be injected subcutaneously, and asked for product to no longer be used and be returned to the recalling firm. An acknowledgement Form was asked to be mailed, e-mailed or faxed back to the firm. Customers with questions were instructed to call 414-918-4280.

Device

Enhancement Medical expression
  • Model / Serial
    Lot numbers to follow: Z36-074, Q36-136, Q36-137, Q36-138, Q36-139, Q36-140, R36-168, R36-169, R36-170, R36-171, R36-172, S36-189, S36-190, S36-191, S36-192, S36-194, S36-202, S36-203.  RECALL EXPANDED 7-8-2014 to include ALL LOTS.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
  • Product Description
    Enhancement Medical expression. model # EXP-150. Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml. || Product Usage: Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
  • Manufacturer
    Enhancement Medical, LLC

Manufacturer

Enhancement Medical, LLC
  • Manufacturer Address
    Enhancement Medical, LLC, 10201 Innovation Drive, Suite 450, Wauwatosa WI 53226
  • Source
    USFDA