BEUDAMED
    FDA Enforcement Class II Terminated

    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.

    Recall: Z-1720-2014 · Reported June 11, 2014

    Enforcement

    Recall Number
    Z-1720-2014
    Event ID
    68039
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Small Bone Innovations, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 11, 2014
    Initiation Date
    April 7, 2014
    Classification Date
    June 4, 2014
    Termination Date
    October 20, 2014
    Address
    1711 S Pennsylvania Ave, Morrisville, PA, 19067-2507, United States

    Description

    SBi RingFix Olive Wires Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, sepsis, limb lengthening, and osteotomy.

    Reason

    Small Bone Innovations (SBI) is recalling non-sterile RingFIX Olive Wires labeled as item #451-3004 Drill tip 1.8 mm diameter 400mm olive k-wire packaged with item #451-3005 Bayonet tip 1.8mm diameter 400mm olive k-wire inside.

    Code Info

    item #451-3004, lot V3R0R.

    Distribution

    US Nationwide Distribution in the states of IN, NC, WA, NH, and CT.

    Quantity

    44