BEUDAMED
    FDA Recall Terminated

    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

    Recall: Z-2821-2018 · Initiated June 8, 2018

    Recall

    Recall Number
    Z-2821-2018
    Event Number
    80534
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 8, 2018
    Terminated
    April 14, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem

    Reason

    Two lots of the Echo BI-Metric Hip Stem and ARCOS Modular Revision Hip Stem may have been comingled. Potential health consequences include extension of surgery time to find a replacement component.

    Action

    The firm sent an initial email on June 6, 2018, to US distributors that received affected product. Distributors were asked to quarantine any affected product on hand. The formal recall notice was then prepared and emailed to distributors on June 8, 2018. On the same day, hospital risk managers and distributors received notification via courier. " The distributors notice identified the issue and their responsibilities. These responsibilities included locating and removing the product in their territory, as well as identifying hospitals who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " The hospital risk manager notice identified the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. If you have further questions or concerns after reviewing this information, please call Zimmer Biomet customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

    Distribution

    US distribution to CA, GA, IL, MO, NY, and VA.

    Quantity

    12