Anthogyr Recalls Axiom 2.8 Dental Implants Due to Design Validation Failure
Anthogyr is recalling 10 units of Axiom 2.8 dental implants because an FDA inspection revealed 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 generally unlikely to cause temporary or medically reversible health consequences. The source text does not report any illnesses, injuries, or deaths, and the hazard is a failure in design validation rather than a confirmed defect causing harm.
Plain-English summary
Anthogyr is recalling 10 units of Axiom 2.8 sterile dental implants. These implants are used as artificial root structures for replacing missing teeth, stabilizing removable prostheses, or fixing single tooth restorations and partial dentures. The specific units involved are sizes 02.8 x 10.0, 02.8 x 12.0, and 02.8 x 14.0.
The recall was initiated following an FDA inspection that determined the firm failed to validate the design and process of its implants. This regulatory finding indicates that the manufacturing and design controls required to ensure the safety and effectiveness of the devices were not properly established or verified.
The affected units were distributed in the United States to the states of North Carolina, New York, and Oregon. Consumers and healthcare providers who have these specific implants should stop using them and contact Anthogyr or their healthcare provider for instructions on how to proceed.
The recalled product
- 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…
- Manufacturer
- Anthogyr
- Category
- Medical Device — Dental Implants
- Affected units
- 10
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 Axiom REG Dental Implants Recalled for Design Validation Failure
FDA (Devices) · 2016-09-14
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