BEUDAMED
    FDA Recall Terminated

    Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

    Recall: Z-2963-2018 · Initiated May 10, 2018

    Recall

    Recall Number
    Z-2963-2018
    Event Number
    80609
    Firm
    Zimmer Dental Inc
    FEI Number
    2023141
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 10, 2018
    Terminated
    August 19, 2020
    Address
    1900 Aston Ave, Carlsbad, CA, 92008-7308

    Description

    Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.

    Reason

    Dental implants have incorrect item/lot numbers and size on the inner package labeling. Correct item/lot numbers and size are on the outer package labeling.

    Action

    The firm, Zimmer Biomet, sent an "Medical Device Recall" notice dated 5/10/2018 via FedEx/UPS courier to its customers. OUS distributors received a "distributor" notice. The notice described the product, problem and actions to be taken. The Customers were instructed to immediately return affected product to Field Action, PM Regulatory Compliance, Zimmer Biomet, 4555 Riverside Dr., Palm Beach Gardens, FL 33410 US and asked to complete and return a Certificate of Acknowledgement. and send to [email protected]. If you have further questions or concerns, please call the Recall Department at 561-776-6700 between 8:00 am and 5:00 pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail. Alternatively, your questions may be emailed to [email protected].

    Distribution

    Worldwide Distribution: US (nationwide) in states of: AL, CA, CO, CT, FL, GA, ID, IL, MA, MD, MI, MN, MO, NH, NJ, NY, PA,TN, TX, UT, VA, and WA; and to countries of: Australia, Bulgaria, Canada, Croatia, France, Germany, Italy, Portugal, and Spain.

    Quantity

    299 units