Keystone Dental Recalls Mislabeled Prima Plus Dental Implants
Keystone Dental Inc is recalling 72 Prima Plus dental implants due to mislabeling. The devices were distributed to dental professionals in 14 US states.
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 involves a labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Keystone Dental Inc is recalling 72 units of the Prima Plus 4.1 x 11.5mm Implant, Catalog Number 15737K. The recall is being conducted because the implants are mislabeled. The devices are intended for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations.
The affected units, identified by UDI D76815737K0 and Lot 37038, were distributed to the states of California, Connecticut, Florida, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Montana, New Jersey, Nevada, New York, Texas, and Virginia. The recall is classified as Class II by the FDA.
Dental professionals who have received these implants should stop using them and contact Keystone Dental Inc for instructions on return or replacement. Patients who have already had these implants placed should consult their dental provider for guidance.
The recalled product
- Product
- Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and…
- Manufacturer
- Keystone Dental Inc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 72
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 (2)
- UDI: D76815737K0
- Lot 37038
Distribution
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