BEUDAMED
    FDA Recall Terminated

    symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container

    Recall: Z-1012-2017 · Initiated November 29, 2016

    Recall

    Recall Number
    Z-1012-2017
    Event Number
    75850
    Firm
    Symmetry Surgical, Inc.
    FEI Number
    3007208013
    Product Code
    KCT
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 29, 2016
    Posted
    January 11, 2017
    Terminated
    August 20, 2017
    Address
    3034 Owen Dr, Antioch, TN, 37013-2413

    Description

    symmetry surgical ULTRA(R) Gravity container, REF numbers: C131310-G, C13134-G, C13135-G, C13136-G, C13139-G, C13854-G, C13855-G, C13856-G, C181310-G, C18134-G, C18135-G, C18136-G, C18138-G, C22854-G, C22855-G, C22856-G, C22858-G, C24134-G, C24135-G, C24136-G, C24138, C24138-G Product Usage: sterilization container

    Reason

    Sealant on the base trim of sterilizer container may be deteriorated or absent which could provide a path for contaminants to enter the container under certain conditions post-sterilization.

    Action

    Siemens sent a Customer Safety Notice letter to customers. The letter identified the affected product problem and actions to be taken. Siemens Customer Service Engineer will contact customers to setup an appointment for installation of the new residual current monitor (RCM).

    Distribution

    Worldwide Distribution

    Quantity

    38 units