BEUDAMED
    FDA Recall 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 · Initiated October 13, 2013

    Recall

    Recall Number
    Z-0353-2014
    Event Number
    66558
    Firm
    Restoration Robotics
    FEI Number
    3006515340
    Product Code
    ONA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 13, 2013
    Posted
    November 18, 2013
    Terminated
    December 10, 2013
    Address
    128 Bayview Drive, San Jose, CA, 95134

    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.

    Action

    Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760

    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)