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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Anthogyr: Following a FDA inspection showing that the firm failed to validate the design and process of its implants.

Agency Publication Date: September 8, 2016
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Affected Products

Product: 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.

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

Lot Numbers:
OP34080
OP34100
OP34120
OP34140
OP34160
OP34180
OP40060
OP40080
OP40100
OP40120
OP40140
OP40160
OP40180
OP46060
OP46080
OP46100
OP46120
OP46140
OP52060
OP52080
OP52100
OP52120
OP52140
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 OP28100 Size 02.8 x 10.0 Code OP28120 Size 02.8 x 12.0 Code OP28140 Size 02.8 x 14.0

Lot Numbers:
OP28100
OP28120
OP28140

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 74722
Status: Resolved
Manufacturer: Anthogyr
Manufactured In: France
Units Affected: 2 products (111 units; 10 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.