Anthogyr Axiom REG Dental Implants Recalled for Design Validation Failure
Anthogyr is recalling 111 units of Axiom REG dental implants because an FDA inspection found the firm failed to validate the design and process of the devices.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which is a moderate severity classification. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to a failure in design validation rather than a confirmed acute safety defect causing harm.
Plain-English summary
Anthogyr is recalling 111 units of Axiom REG sterile dental implants. These implants are used as artificial root structures for the replacement of missing teeth, for the stabilization of removable prostheses, or for the fixation of single tooth restorations or partial dentures.
The recall was initiated following an FDA inspection that determined the firm failed to validate the design and process of its implants. The affected units were distributed in the United States to the states of North Carolina, New York, and Oregon. The recall covers various sizes and codes, including diameters of 03.4, 04.0, 04.6, and 05.2 mm with various lengths.
Consumers and healthcare providers who have these specific implants should contact Anthogyr for further instructions on how to proceed with the recall and replacement of the devices.
The recalled product
- 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…
- Manufacturer
- Anthogyr
- Category
- Medical Device — Dental Implants
- Affected units
- 111
Distribution
Part of a larger recall action
This product is one of 2 recalled by Anthogyr under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Anthogyr
See all →- ModerateAnthogyr Recalls Axiom 2.8 Dental Implants Due to Design Validation Failure
FDA (Devices) · 2016-09-14
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