BEUDAMED
    FDA Recall Terminated

    PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

    Recall: Z-1224-2018 · Initiated December 12, 2017

    Recall

    Recall Number
    Z-1224-2018
    Event Number
    79394
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    JHW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 12, 2017
    Terminated
    April 9, 2019
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    PERSONA THE PERSONALIZED KNEE SYSTEM "PSN TIB STM 5 DEG SZ D R" indicated for patients with severe knee pain and disability due to: - Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.

    Reason

    A complaint was received for Item 42-5320-067-02, lot 63236047. It was report that there was no set screw or taper plug included in the box. Complaint investigation confirmed that the entire lot of 63236047 was missing the set screw and taper plug.

    Action

    On December 12, 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers will the following guidance: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. Questions or concerns can be directed to 1-574-371-3071.

    Distribution

    Non-USA Customer

    Quantity

    3 units