BEUDAMED
    FDA Recall Terminated

    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

    Recall: Z-1099-2022 · Initiated April 19, 2022

    Recall

    Recall Number
    Z-1099-2022
    Event Number
    90078
    Firm
    Smith & Nephew Inc
    FEI Number
    3005551626
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 19, 2022
    Terminated
    August 16, 2024
    Address
    6409 E Holmes Rd, Memphis, TN, 38141-8310

    Description

    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

    Reason

    It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

    Action

    Initial consignees were notified via email and overnight mail on 04/19/2022. The consignees were instructed to inspect their inventory, return affected product, and complete the response form.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of CT, NC, CO, SC, VA, FL, IL, CA and the country of Japan.

    Quantity

    16 units