Unapproved Dental Implants Recalled by Instradent USA
Instradent USA is recalling 13 units of Neodent Titamax WS Cortical Implants because the product is not approved for use in the US.
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, and the source text explicitly states no illnesses or injuries have been reported, limiting the severity to a theoretical risk of harm.
Plain-English summary
Instradent USA, Inc. is recalling 13 units of Neodent Titamax WS Cortical Implants (4.0 x 5 mm, Article Number 109.604). The recall is being conducted because the product is not approved for use in the United States.
The affected dental implants were distributed nationwide, including in Arizona, California, New York, and Massachusetts. The specific lot number for the recalled units is 800115427.
Consumers and healthcare providers who have purchased or received these specific implants should stop using them and contact Instradent USA, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous…
- Manufacturer
- Instradent USA, Inc.
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 13
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: 800115427
Distribution
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