BEUDAMED
    FDA Enforcement Class II Terminated

    ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

    Recall: Z-0376-2019 · Reported November 14, 2018

    Enforcement

    Recall Number
    Z-0376-2019
    Event ID
    81065
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Coltene Whaledent Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 14, 2018
    Initiation Date
    August 21, 2018
    Classification Date
    November 2, 2018
    Termination Date
    April 10, 2020
    Address
    235 Ascot Pkwy, Cuyahoga Falls, OH, 44223-3701, United States

    Description

    ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

    Reason

    ParaPost Plus Titanium Posts contain stainless steel post that are a size 4

    Code Info

    Batch I33012

    Distribution

    US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.

    Quantity

    30 packets