BEUDAMED
    FDA Enforcement Class II Terminated

    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.

    Recall: Z-2545-2014 · Reported September 3, 2014

    Enforcement

    Recall Number
    Z-2545-2014
    Event ID
    68934
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 3, 2014
    Initiation Date
    July 30, 2014
    Classification Date
    August 25, 2014
    Termination Date
    January 20, 2015
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.

    Reason

    Internal review found that five (5) PFJ implant forgings were identified as have forged laps during receiving inspection process for raw material. These five forgings were not segregated and were subsequently issued to final manufacturing under Part 00-5926-014-01; lot 62455332. A forged lap is a defect that forms when metal folds over itself during forging.

    Code Info

    00-5926-014-01; Lot 62455332

    Distribution

    Worldwide Distribution - US (nationwide) in the states of HI, CA, GA, MI, and IL and the countries of TAIWAN, BELGIUM, AUSTRALIA, FRANCE, JAPAN, and UK.

    Quantity

    15 units