BEUDAMED
    FDA Recall Terminated

    Rifton TRAM Low Base, SKU K320, powered lift device

    Recall: Z-0165-2020 · Initiated March 21, 2019

    Recall

    Recall Number
    Z-0165-2020
    Event Number
    82607
    Firm
    Community Products, LLC
    FEI Number
    1319061
    Product Code
    FSA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 21, 2019
    Terminated
    June 15, 2020
    Address
    2032 Route 213, Rifton, NY, 12471

    Description

    Rifton TRAM Low Base, SKU K320, powered lift device

    Reason

    A design change to the load-bearing quick release buckle renders the springs in the latch mechanism susceptible to fatigue failure after repeated use.

    Action

    Urgent Medical Device Correction emails were sent to customers beginning on March 21, 2019. Customers were contacted via telephone beginning April 5, 2019.

    Distribution

    The products were distributed US nationwide. The products were distributed to the following foreign countries: Foreign Countries: Worldwide, including Canada, United Kingdom, Germany, Japan, Singapore, South Korea, United Arab Emirates, Taiwan, Denmark, Italy, Hong Kong, Ireland, Australia, New Zealand, Israel, Colombia, Russia

    Quantity

    1079