BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2545-2014 · Initiated July 30, 2014

    Recall

    Recall Number
    Z-2545-2014
    Event Number
    68934
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    KRR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 30, 2014
    Posted
    August 26, 2014
    Terminated
    January 20, 2015
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    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.

    Action

    Zimmer sent an URGENT MEDICAL DEVICE RECALL letter dated July 2014 to affected distributors and hospital accounts. The letter identified the affected product, problem and the actions to be taken. The letter instructed customers to 1. Review the notification and ensure affected personnel are aware of the contents, 2. Locate and quarantine any affected product listed above and notify your Zimmer sales representative, and 3. Your Zimmer sales representative will remove the recalled product from your facility. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.

    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