BEUDAMED
    FDA Recall Terminated

    Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

    Recall: Z-1705-2018 · Initiated April 5, 2018

    Recall

    Recall Number
    Z-1705-2018
    Event Number
    79987
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JEY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 5, 2018
    Posted
    May 7, 2018
    Terminated
    August 12, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Lactosorb RapidFlap, bone plate, Model No. 915-0020 The RapidFlap LS Cranial Fixation System is indicated for use in pediatric craniotomy flap fixation.

    Reason

    The recalling firm has confirmed that the Outer Plate component exhibits an excessive chamfer on the threading after deburring operations. This excessive chamfer results in non-conforming product where the threads of the outer plate component have limited to no engagement with the post component.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall letter dated April 5, 2018, to Distributors, Sales Representatives, and Distribution Managers. A separate recall letter was sent to Risk Managers on the same date. (Updated 3/20/19) On February 12, 2019, the firm issued notification of recall expansion. Further affected lots had been identified as part of the recall, and affected customers were notified. (/Update) Consignees were informed of the product issue and risk of non-functioning device and delays in surgery. All parties were instructed to review the notice, locate and quarantine affected product in inventory, return all affected product with a completed return form and mark "RECALL" on the outside of returned cartons, and return the completed customer response form. If you have further questions or concerns regarding this recall, please call (904)741-4400 extension 9133 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a voicemail prompt. For further questions, please call (574) 371-3071. (Updated 3/20/19) Alternatively, your questions may be emailed to [email protected]. (/Update)

    Distribution

    worldwide Distribution - US Distribution to the states of : CA, FL, MO, NC, SC, TX, and WI., and to the countries of : Argentina, China, Colombia, Germany, Japan, Netherlands, South Africa, Thailand, and Vietnam.

    Quantity

    13175