CLASS II Device recall · Reported 14 Sep 2016 · FDA Enforcement Report
Axiom REG implants Sterile The Axiom REG implants are used recalled
Anthogyr is recalling Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures, distributed in North Carolina, New York, Oregon. The recall was initiated on 20 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2753-2016
- FDA event ID
- 74722
- Recalling firm
- Anthogyr, Sallanches
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Jun 2016
- FDA classified
- 8 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Dental Devices
Timeline
| 20 Jun 2016 | Recall initiated by company | |
| 8 Sep 2016 | Classified by FDA | +80 days |
| 14 Sep 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Axiom REG 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.
Where it was distributed
US Distribution to sates of: NC, NY, and OR.
Questions about this recall
Is Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures recalled?
Yes. Anthogyr recalled Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures on 20 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2753-2016.
Why was it recalled?
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
Which lots are affected?
Code OP34080 Size 03.4 x 8.0 Code OP34100 Size 03.4 x 10.0 Code OP34120 Size 03.4 x 12.0 Code OP34140 Size 03.4 x 14.0 Code OP34160 Size 03.4 x 16.0 Code OP34180 Size 03.4 x 18.0 Code OP40060 Size 04.0 x 6.5 Code OP40080 Size 04.0 x 8.0 Code OP40100 Size 04.0 x 10.0 Code OP40120 Size 04.0 x 12.0 Code OP40140 Size 04.0 x 14.0 Code OP40160 Size 04.0 x 16.0 Code OP40180 Size 04.0 x 18.0 Code OP46060 Size 04.6 x 6.5 Code OP46080 Size 04.6 x 8.0 Code OP46100 Size 04.6 x 10 Code OP46120 Size 04.6 x 12 Code OP46140 Size 04.6 x 14 Code OP52060 Size 05.2 x 6.5 Code OP52080 Size 05.2 x 8.0 Code OP52100 Size 05.2 x 10.0 Code OP52120 Size 05.2 x 12.0 Code OP52140 Size 05.2 x 14.0
Where was it sold?
US Distribution to sates of: NC, NY, and OR.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Anthogyr
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Axiom 8 implants Sterile The Axiom REG implants are used as recalled | Anthogyr | Sterility | NC, NY, OR |
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| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |