BEUDAMED
    FDA Enforcement Class II Terminated

    Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.

    Recall: Z-0353-2014 · Reported November 27, 2013

    Enforcement

    Recall Number
    Z-0353-2014
    Event ID
    66558
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Restoration Robotics
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 27, 2013
    Initiation Date
    October 13, 2013
    Classification Date
    November 18, 2013
    Termination Date
    December 10, 2013
    Address
    128 Bayview Drive, San Jose, CA, 95134, United States

    Description

    Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.

    Reason

    Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.

    Code Info

    Model number FP-45384

    Distribution

    Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.

    Quantity

    515 in US. 315 International.(included all packaging configurations)