BEUDAMED
    FDA Recall Terminated

    RePlant Angled Abutment Part Number 6050-52-60

    Recall: Z-2320-2016 · Initiated July 5, 2016

    Recall

    Recall Number
    Z-2320-2016
    Event Number
    74624
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 5, 2016
    Posted
    August 2, 2016
    Terminated
    February 16, 2017
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    RePlant Angled Abutment Part Number 6050-52-60

    Reason

    Issue with design specification; oversized condition.

    Action

    Implant Direct sent an Urgent: Medical Device Field Corrective Action letter dated July 6, 2016, to all affected customers. The letter requests that it be reviewed and determined if customer has any affected product in inventory. Customers are asked to complete and return the Acknowledgement and Recall Return Form within 48 hours. If customers are an authorized Implant Direct Sybron Manufacturing distributor, they request that customers identify those customers that may have been shipped the affected product lot and contact these customers to inform them of this issue within fortyeight (48) hours of receipt of the notification in order to provide the customers with the correct tool. If customers have any of the affected product listed the firm will send a replacement part. If any questions contact Implant Direct Sybron Manufacturing LLC Customer Care at 1-888-649-6425.

    Distribution

    U.S. distribution to the following; CA, WA, UT, GA, AZ, NE, OR, MI, TX, WI, FL, AL, AR, MO, VA, MA, TN, LA, NC, KS, NY, SC, OK. Foreign distribution to the following; CA, DE, IT, GB, PL, DE, GB, NL, GR, ES, HR, BG.

    Quantity

    205