BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-2135-2014 · Initiated August 7, 2013

    Recall

    Recall Number
    Z-2135-2014
    Event Number
    68596
    Firm
    Enhancement Medical, LLC
    FEI Number
    3008404291
    Product Code
    LMH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 7, 2013
    Posted
    August 8, 2014
    Terminated
    September 29, 2017
    Address
    10201 Innovation Drive, Suite 450, Wauwatosa, WI, 53226

    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.

    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.

    Distribution

    Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.

    Quantity

    17,875