BEUDAMED
    FDA Recall Terminated

    All instrumentation associated with the Prelude PF Resurfacing Knee System.

    Recall: Z-1318-2016 · Initiated March 9, 2016

    Recall

    Recall Number
    Z-1318-2016
    Event Number
    73489
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KRR
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 9, 2016
    Posted
    April 4, 2016
    Terminated
    May 23, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    All instrumentation associated with the Prelude PF Resurfacing Knee System.

    Reason

    Inadequate design control.

    Action

    Zimmer Biomet sent an "Urgent Medical Device Recall Notice" dated March 9, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The following actions are REQUIRED: 1. Immediately locate and remove the identified device(s) listed below from circulation. 2. Carefully follow the instructions on the enclosed Response Form. 3.Email a copy of the response form to CPW [email protected] prior to return of product. 4. Use priority carrier for your shipment. Please confirm receipt of this notice by sending back the response form within three (3) business days. Thank you in advance for your assistance and prompt attention. On behalf of Zimmer Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    US Distribution to the states of : CA, CO, GA, IN, KS, MI, MO, NC, NJ, OH, TN and TX.

    Quantity

    576