BEUDAMED
    FDA Recall 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 · Initiated January 23, 2015

    Recall

    Recall Number
    Z-1265-2015
    Event Number
    70524
    Firm
    Southern Implants, Inc
    FEI Number
    3003845138
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    January 23, 2015
    Posted
    March 12, 2015
    Terminated
    May 20, 2015
    Address
    5 Holland, Ste 209, Irvine, CA, 92618-2576

    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.

    Action

    A customer notification letter dated 1/23/15 was sent to customers to inform them that Southern Implant is recalling the MAX-TL 9.0x7.0mm Implant because it may contain a Z-MAX9-7 Implant, 9mm diameter, 7mm length. Customers are instructed to return the fax back form and to contact customer relations depart at (866) 902-9272.

    Distribution

    US Nationwide Distribution.

    Quantity

    130 units