Recall Z-2754-2016— Anthogyr
Class II · Terminated
Class II FDA medical device recall by Anthogyr, initiated 2016-06-20, terminated 2017-03-28. It names one FDA 510(k) clearance: K141450. Product: 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..
- Recalling firm
- Anthogyr
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-20
- Terminated
- 2017-03-28
- Firm location
- Sallanches, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.