BEUDAMED
    FDA Enforcement Class II Terminated

    EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

    Recall: Z-1674-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1674-2015
    Event ID
    71067
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DePuy Spine, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2015
    Initiation Date
    April 21, 2015
    Classification Date
    May 26, 2015
    Termination Date
    October 3, 2018
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199, United States

    Description

    EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467

    Reason

    Device does not mate as intended.

    Code Info

    LOT NUMBER: ARNDC6 & ARN DC7

    Distribution

    US: PA and OUS: SE, BE, IT, PT

    Quantity

    183 devices