BEUDAMED
    FDA Enforcement Class II Terminated

    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.

    Recall: Z-0246-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0246-2023
    Event ID
    91016
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Novapproach Spine LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    November 23, 2022
    Initiation Date
    October 12, 2022
    Classification Date
    November 17, 2022
    Termination Date
    April 1, 2026
    Address
    13900 Tech City Cir Ste 300, N/A, Alachua, FL, 32615-6091, United States

    Description

    OneLIF Torque Limiting Adapter, AO to 1/4 SQ, 2.25Nm Limit, Catalog #015-010-0000, a component of NovApproach Spine OneLIF Interbody System instrument kit, Catalog #OneLIF INS.

    Reason

    The torque limiting adapter may not stay locked inside of the ratcheting handle once fully engaged.

    Code Info

    Torque adapter - Lot #104713, UDI G07001501000000; Kit IDs - 504, 505, 506, 501, 101, and 105.

    Distribution

    US Nationwide distribution in the states of CA and NY.

    Quantity

    6 devices