BEUDAMED
    FDA Recall Terminated

    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.

    Recall: Z-2456-2015 · Initiated July 20, 2015

    Recall

    Recall Number
    Z-2456-2015
    Event Number
    71815
    Firm
    Trilliant Surgical Ltd.
    FEI Number
    3007420745
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 20, 2015
    Posted
    August 24, 2015
    Terminated
    January 26, 2017
    Address
    6721 Portwest Dr, Ste 160, Houston, TX, 77024-8019

    Description

    Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.

    Reason

    The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.

    Action

    The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments.

    Distribution

    Nationwide throughout the US

    Quantity

    638 units