BEUDAMED
    FDA Enforcement Class II Terminated

    Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

    Recall: Z-2753-2016 · Reported September 14, 2016

    Enforcement

    Recall Number
    Z-2753-2016
    Event ID
    74722
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Anthogyr
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 14, 2016
    Initiation Date
    June 20, 2016
    Classification Date
    September 8, 2016
    Termination Date
    March 28, 2017
    Address
    2237 Avenue Andre Lasquin, Sallanches, N/A, France

    Description

    Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. There are different diameters and different lengths for each diameter.

    Reason

    Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

    Code Info

    Code OP34080 Size 03.4 x 8.0 Code OP34100 Size 03.4 x 10.0 Code OP34120 Size 03.4 x 12.0 Code OP34140 Size 03.4 x 14.0 Code OP34160 Size 03.4 x 16.0 Code OP34180 Size 03.4 x 18.0 Code OP40060 Size 04.0 x 6.5 Code OP40080 Size 04.0 x 8.0 Code OP40100 Size 04.0 x 10.0 Code OP40120 Size 04.0 x 12.0 Code OP40140 Size 04.0 x 14.0 Code OP40160 Size 04.0 x 16.0 Code OP40180 Size 04.0 x 18.0 Code OP46060 Size 04.6 x 6.5 Code OP46080 Size 04.6 x 8.0 Code OP46100 Size 04.6 x 10 Code OP46120 Size 04.6 x 12 Code OP46140 Size 04.6 x 14 Code OP52060 Size 05.2 x 6.5 Code OP52080 Size 05.2 x 8.0 Code OP52100 Size 05.2 x 10.0 Code OP52120 Size 05.2 x 12.0 Code OP52140 Size 05.2 x 14.0

    Distribution

    US Distribution to sates of: NC, NY, and OR.

    Quantity

    111 units