BEUDAMED
    FDA Recall Terminated

    MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia.

    Recall: Z-0145-2012 · Initiated August 18, 2011

    Recall

    Recall Number
    Z-0145-2012
    Event Number
    60046
    Firm
    Merz Aesthetics, Inc.
    FEI Number
    3003407669
    Product Code
    LMH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 18, 2011
    Posted
    November 1, 2011
    Terminated
    May 1, 2012
    Address
    4133 Courtney Rd, Ste 10, Franksville, WI, 53126-9127

    Description

    MERZ AESTHETICS, Radiesse Volume Advantage 1.5 CC, Injectable Implant, Part Number 8071M0H1 and 8071M0K1, Sterile, Rx ONLY. Part Number 8071M4K1 distributed in Canada Part Number 8071M5 distributed in Europe/Middle East/Africa Part Number 8071M9 distributed in Hong Kong, Korea, Malaysia.

    Reason

    There is a potential leakage of product that may occur with Merz Aesthetics 1.5cc syringes of Radiesse Dermal Filler. When using the syringe, Health Care Professionals should be alerted to the potential for product that my leak pass the plunger at the proximal end of the syring. The defect may result in infection requiring medical intervention to prevent impairment or damage. To date Merz has n

    Action

    On 8/18/11, consignees were sent a Merz Aesthetics "Urgent Medical Device Recall" letter dated August 15, 2011. The letter was addressed to "Dear Health Care Professional". The letter described the product and the problem and listed the details regarding this issue.

    Distribution

    Worldwide distribution including USA, Puerto Rico, Dominican Republic, Hong Kong, Israel, Netherlands, Germany, South Korea, and Canada.

    Quantity

    311,582