BEUDAMED
    FDA Recall 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 · Initiated April 7, 2014

    Recall

    Recall Number
    Z-1720-2014
    Event Number
    68039
    Firm
    Small Bone Innovations, Inc.
    FEI Number
    3003640913
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    April 7, 2014
    Posted
    June 4, 2014
    Terminated
    October 20, 2014
    Address
    1711 S Pennsylvania Ave, Morrisville, PA, 19067-2507

    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.

    Action

    SBi sent an Urgent Medical Device Recall dated April 7, 2014, to affected customers (sales consultants, distributors, and end users). The letter identified the affected product, problem and actions to be taken. For questions call 215-428-1791 ext 248.

    Distribution

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

    Quantity

    44