BEUDAMED
    FDA Enforcement Class II Terminated

    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    Recall: Z-1512-2016 · Reported April 27, 2016

    Enforcement

    Recall Number
    Z-1512-2016
    Event ID
    73382
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ossur H / F
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 27, 2016
    Initiation Date
    March 14, 2016
    Classification Date
    April 19, 2016
    Termination Date
    August 16, 2016
    Address
    Grjothals 5, N/A, Reykjavik, N/A, N/A, Iceland

    Description

    Ossur Lil Angel Vest P2 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.

    Reason

    There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.

    Code Info

    P/N: 545100S units from 2008 to current

    Distribution

    Distribution US Nationwide and Hong Kong

    Quantity

    435 total all models