Reported Sep 14, 2016 · Terminated
Axiom REG implants Sterile The Axiom REG implants are used as artificial root structures for replacement of missing…
Anthogyr
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Anthogyr · 2237 Avenue Andre Lasquin · Sallanches · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- 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
- Amount recalled
- 111 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Following a FDA inspection showing that the firm failed to validate the design and process of its implants.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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