BEUDAMED
    FDA Enforcement Class II Terminated

    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

    Recall: Z-0026-2016 · Reported October 14, 2015

    Enforcement

    Recall Number
    Z-0026-2016
    Event ID
    71899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ortho Solutions Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 14, 2015
    Initiation Date
    July 14, 2015
    Classification Date
    October 6, 2015
    Termination Date
    April 26, 2017
    Address
    330 Franklin Tnpk, N/A, Mahwah, NJ, 07430, United States

    Description

    Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw

    Reason

    Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking thread feature of the screw was not manufactured to specification. As a consequence there is a risk that a screw may not lock onto the plate at the time of primary insertion into the plate and the bone. In the event of this occurring the non functioning screw would need to be replaced with an alternativ

    Code Info

    Part Number (Lot Number) infomration is as follows: OS421712-NS (lot 7891), OS421714-NS (lot 7891) OS421716-NS (lot 7891, 7520), OS421718-NS (lot 7891, 7520) OS421720-NS (lot 7891), OS421722-NS (lot 7891, 7520) OS421724-NS (lot 7891, 7520), OS421726-NS (lot 7891) OS421728-NS (lot 7891), OS421730-NS (lot 7891) OS421735-NS (lot 7520, 7891) ,OS421740-NS (lot 7520, 7891) OS421745-NS (lot 7520, 7891) ,OS421750-NS (lot 7520, 7891) OS421716 (lot 7519) ,OS421718 (lot 7519)

    Distribution

    US Distribution to states of: CA, CO, GA, IL, LA, NC, NY, TX and WA.

    Quantity

    875 units