BEUDAMED
    FDA Recall Terminated

    PremierPro Aluminum Adjustable Walker

    Recall: Z-0487-2019 · Initiated October 1, 2018

    Recall

    Recall Number
    Z-0487-2019
    Event Number
    81367
    Firm
    SVS LLC
    FEI Number
    3007304336
    Product Code
    ITJ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 1, 2018
    Terminated
    July 13, 2020
    Address
    14120 Ballantyne Corporate Pl, Ste 425, Charlotte, NC, 28277-2891

    Description

    PremierPro Aluminum Adjustable Walker

    Reason

    This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.

    Action

    SVS LLC, dba S2S Global notified customers initially via telephone on about 10/01/2018 and followed up with a "Notice of Product Recall" letter on about 10/03/2018. The letter requested customers check inventory for affected walkers, quarantine any on hand, make arrangements to return the affected walkers, and complete and return the Medical Device Acknowledgement & Return Response Form.

    Distribution

    US distribution to OH, NY,TX, PA

    Quantity

    256 devices