BEUDAMED
    FDA Enforcement Class II 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 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2456-2015
    Event ID
    71815
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trilliant Surgical Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2015
    Initiation Date
    July 20, 2015
    Classification Date
    August 24, 2015
    Termination Date
    January 26, 2017
    Address
    6721 Portwest Dr Ste 160, N/A, Houston, TX, 77024-8019, United States

    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.

    Code Info

    TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708

    Distribution

    Nationwide throughout the US

    Quantity

    638 units