BEUDAMED
    FDA Recall Terminated

    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.

    Recall: Z-1651-2014 · Initiated April 23, 2014

    Recall

    Recall Number
    Z-1651-2014
    Event Number
    68223
    Firm
    Heraeus Kulzer, LLC.
    FEI Number
    1821514
    Product Code
    LBH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 23, 2014
    Posted
    May 23, 2014
    Terminated
    November 5, 2014
    Address
    300 Heraeus Dr, South Bend, IN, 46614-2557

    Description

    Gluma Desensitizer Power Gel Product Usage: Usage: This is a class 2 medical device. For reduction or elimination of pain in exposed cervical areas that do not require restoration. It is also used for alleviation or reduction of dentinal sensitivity after preparation of teeth to receive fixed prosthesis or restorations.

    Reason

    The firm discovered that the Gluma Desensitizer Power Gel can be inadvertently extruded from the application syringe all at once when it is supposed to extrude on the desired area a small amount at a time. If extruded all at once, product could reach the dental patients mucosa, face or eyes or the dental professional could be exposed. This would cause irritation, burning or blistering.

    Action

    Heraeus Kulzer sent a Voluntary Recall letter dated April 22, 2014 to all affected doctors and supply centers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: 1. Inspect your inventory, both in storage and in use, and identify the lot number on your kits and syringes. Refer to attached images. 2. If you identify any Gluma Desensitizer PowerGel with the aforementioned kit or syringe lot numbers, immediately cease usage of this product and call Technical Services at 1 (574) 299-5409 3. Please advise if you forwarded this product to any other end users. We will need their contact information inClusive of name, address and phone number. For questions regarding this notification, please call our Technical Service team at (574) 299-5409.

    Distribution

    US Nationwide Distribution in the states of GA, TX, IL, CA, WA, WI, HI, MO, FL, NJ, TN, PA, NY, NC, OH, IN, CT, KY, AZ, NV, IA,

    Quantity

    5,112 syringes or 1,278 kits (1 Kit=4 syringes)