FDA Enforcement
Class II
Terminated
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.
Recall: Z-2754-2016
·
Reported September 14, 2016
Enforcement
- Recall Number
- Z-2754-2016
- 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 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
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Code Info
Code OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0
Distribution
US Distribution to sates of: NC, NY, and OR.
Quantity
10 units