BEUDAMED
    FDA Enforcement Class II Terminated

    MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.

    Recall: Z-1265-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1265-2015
    Event ID
    70524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Southern Implants, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    January 23, 2015
    Classification Date
    March 11, 2015
    Termination Date
    May 20, 2015
    Address
    5 Holland Ste 209, N/A, Irvine, CA, 92618-2576, United States

    Description

    MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7. Dental implant. Product Usage: The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.

    Reason

    Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length. And vice versa.

    Code Info

    MAX-TL Lot# 1244041400 Z-MAX9-7 Lot# 1238041402

    Distribution

    US Nationwide Distribution.

    Quantity

    130 units