BEUDAMED
    FDA Recall Terminated

    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.

    Recall: Z-0833-2018 · Initiated August 31, 2017

    Recall

    Recall Number
    Z-0833-2018
    Event Number
    79115
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    HSD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 31, 2017
    Terminated
    March 12, 2020
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.

    Reason

    The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.

    Action

    On September 11, 2017 an URGENT MEDICAL DEVICE RECALL notice was issued to customers for specific lots of the DELTA XTEND Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants. The letter instructs customers to inspect inventory and to remove and return the affected lots to the recalling firm. Questions or concerns can be directed to Kim (Earle) Long, Senior Recall Coordinator, 574-371-4917.

    Distribution

    Nationally

    Quantity

    23,053 units