BEUDAMED
    FDA Recall Terminated

    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.

    Recall: Z-0626-2021 · Initiated November 25, 2020

    Recall

    Recall Number
    Z-0626-2021
    Event Number
    86896
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 25, 2020
    Posted
    December 17, 2020
    Terminated
    May 8, 2024
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofacial bone.

    Reason

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    Action

    On November 25, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the potential loss of sterility in affected devices. Customers were asked to do the following: Risk Manager Responsibilities: 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. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals and ensure documentation. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. All customers should also complete the certificate of acknowledgement included with the letter and return to the firm. If you have further questions or concerns after reviewing this notice, please call 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

    Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

    Quantity

    7428