BEUDAMED
    FDA Recall Terminated

    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

    Recall: Z-2316-2015 · Initiated June 16, 2015

    Recall

    Recall Number
    Z-2316-2015
    Event Number
    71300
    Firm
    Symmetry Surgical, Inc.
    FEI Number
    3007208013
    Product Code
    HXD
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    June 16, 2015
    Posted
    July 30, 2015
    Terminated
    May 26, 2016
    Address
    3034 Owen Dr, Antioch, TN, 37013-2413

    Description

    SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP, REF 19-4137, STERILE EO, Rx only. Apply clamps parallel to the skin with the angled jaws forming a "V" shape between clamp and drape.

    Reason

    Lack of sterility assurance.

    Action

    The firm initiated their recall by via US certified mail, with return receipt requested, beginning on 06/18/2015. The Urgent Medical Device Recall letter, dated June 16, 2015, identified the affected product, as well as the reason for the recall. The letter discussed the potential harm associated with the issue, and requested that the consignees examine their inventory and discontinue use immediately. Customers should promptly call (800) 251-3000 for a return material authorization (RMA) number to support the return of the impacted lots. Symmetry Surgical Customer Service should be contacted with questions or any other needs.

    Distribution

    Worldwide Distribution -- US, including the states of CA, VA, TX, FL, OH, NY, MS, KY, UT, GA, PA, MO, IN, NV, AL, MI, MA, and LA; and, the countries of Germany and Mexico.

    Quantity

    2,708 units