BEUDAMED
    FDA Recall Terminated

    Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn

    Recall: Z-1582-2017 · Initiated January 9, 2017

    Recall

    Recall Number
    Z-1582-2017
    Event Number
    76255
    Firm
    Resource Optimization & Innovation Llc
    FEI Number
    3004513970
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 9, 2017
    Terminated
    September 28, 2018
    Address
    2909 N Neergard Ave, Springfield, MO, 65803-6317

    Description

    Regard, Item Number: 800414, Sterile, OR0483 - Total Joint PK - Spohn

    Reason

    Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.

    Action

    ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.

    Distribution

    US Distribution to LA and TX.

    Quantity

    120 kits