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U.S. Department of Health and Human Services

Class 2 Device Recall Axiom 2.8

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  Class 2 Device Recall Axiom 2.8 see related information
Date Initiated by Firm June 20, 2016
Date Posted September 08, 2016
Recall Status1 Terminated 3 on March 28, 2017
Recall Number Z-2754-2016
Recall Event ID 74722
510(K)Number K141450  
Product Classification Implant, endosseous, root-form - Product Code DZE
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.
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
Recalling Firm/
Manufacturer		 Anthogyr
2237 Avenue Andre Lasquin
Sallanches France
For Additional Information Contact Mike Foley
404-718-9689
Manufacturer Reason
for Recall		 Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
FDA Determined
Cause 2		 Device Design
Action The firm, Anthogyr, contacted physicians by phone and sent an " URGENT: MEDICAL DEVICE RECALL" notification by mail, dated 06/20/2016, informing users of a recall due to inadequate validation of design and process of implants by the FDA. The notice described the product, problem and actions to be taken. The physicians were instructed to isolate the parts and return any Anthogyr implants from lots subject to recall to Business Area Manager, 247 SouthWest 28th road, Miami, FL 33129;and complete and return the RETURN RESPONSE form by fax to: +33 (0)4 50 93 78 60 or e.mail: j.duthil@anthogyr.com or mail: Anthogyr- Director of Quality & Regulatory Affairs- 2237 avenue- Andre Lasquin-France. The firm stated that they will not market their products in the United States until they obtain validation through 21 CFR Part 820. If you have any questions, call 404-718-9689 or email: jduthil@anthogyr.com or mfoley@anthogyr.com.
Quantity in Commerce 10 units
Distribution US Distribution to sates of: NC, NY, and OR.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DZE and Original Applicant = ANTHOGYR SAS
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