Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing teet
FDA device recall Z-2753-2016 · posted 2016-09-08 · Terminated
Recall details
- Recalling firm
- Anthogyr
- Reason for recall
- Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DZE
- Quantity affected
- 111 units
- Distribution
- US Distribution to sates of: NC, NY, and OR.
- Date initiated
- 2016-06-20
- Date posted
- 2016-09-08
- Date terminated
- 2017-03-28
- Location
- Sallanches, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANTHOFIT OI, ANTHOFIT HE, OSSFIT AND AXIOM (K101913) | Anthogyr Sas | 2011-03-11 |