BEUDAMED
    FDA Recall Terminated

    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

    Recall: Z-0363-2020 · Initiated October 26, 2018

    Recall

    Recall Number
    Z-0363-2020
    Event Number
    83794
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    October 26, 2018
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, 4.3mmD x 11.5mmL, 3.4mmD Platform, RX only, Sterile R Dental Implant

    Reason

    packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

    Action

    On 10/25/2018, a "URGENT: MEDICAL DEVICE RECALL" letter was sent to consignees via FedEx Priority overnight. The notification stated the following: 1. Please review your inventory for the affected product. 2. Please complete and return the Acknowledgement Form within 48 hours for the product listed above; Quarantine product and return product listed above. 3. If you are an authorized Implant Direct Sybron Manufacturing LLC distributor, we request that you 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 this notification. 4.If you have any of the affected product listed above, please return the product and we will send you a replacement part. 5.If you have any questions contact Implant Direct Sybron LLC Customer Care at 888-649-6425. Customer Care is available Monday through Friday, between the hours of 5am-5pm PST. 6. If you or your patients have experienced any issues as a result of the affected products noted in this communication, you may voluntarily report the incident to the FDA through the MEDWATCH reporting system at the following: http://www.fda.gov/Safety/MedWatch/HowToReport/ucm053074.htm

    Distribution

    US distribution in the states of: CA, UT, VA, NY, IL, AR, TX, OH, NV, FL, ID, AK, NC, KS, MN, AZ, CO,

    Quantity

    53 implants