BEUDAMED
    FDA Enforcement Class II Terminated

    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    Recall: Z-0628-2014 · Reported January 15, 2014

    Enforcement

    Recall Number
    Z-0628-2014
    Event ID
    67039
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Materialise USA LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    January 15, 2014
    Initiation Date
    November 26, 2013
    Classification Date
    January 3, 2014
    Termination Date
    January 14, 2014
    Address
    44650 Helm Ct, Plymouth, MI, 48170-6061, United States

    Description

    REF 42-411571 QTY 1 CATALOG CAUTION. SEE INSTRUCTIONS FOR USE SIGNATURE M PKA GDE/MDL SET SML-MP DD.....R-FEB55RKA-T JA-A01 05551 PKA POST CUT SML-PKA MICROPLASTY CUSTOM-MADE DEVICE non-sterile The Signature Personalized Patient Care System includes the patient-specific Signature Guides which are patient specific instruments (guides are considered custom-made per EU definition) intended for use during the surgical procedure for total and partial knee arthroplasty.

    Reason

    Shipped femur guide contained a non-conformance which could possibly impact fit of the drill insert.

    Code Info

    Lot 094929

    Distribution

    US Distribution: MO only.

    Quantity

    1