BEUDAMED
    FDA Recall Terminated

    MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.

    Recall: Z-2698-2020 · Initiated June 18, 2020

    Recall

    Recall Number
    Z-2698-2020
    Event Number
    85899
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 18, 2020
    Terminated
    April 13, 2021
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair, osteotomies, and selective orthognathic surgery of the maxilla and chin.

    Reason

    One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly identifies a shorter length for the screw.

    Action

    DePuy Synthes issued urgent field safety notice in June 2020 to notify customers. The affiliates in the impacted countries will notify affected customers.

    Distribution

    International distribution including in the countries of Australia, Belgium, Chile, France, Slovakia, South Korea.

    Quantity

    104 units