Home / Recalls / Anthogyr / Z-2754-2016

Z-2754-2016 Class II Terminated

Recalled by Anthogyr — Sallanches

Recall Details

Product Type: Devices
Report Date: September 14, 2016
Initiation Date: June 20, 2016
Termination Date: March 28, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10 units

Product Description

Axiom 2.8 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 for Recall

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

Distribution Pattern

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

Code Information

Code OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0