Keystone Dental Recalls Multi-Unit Abutments Due to Screw Fit Issues
Keystone Dental Inc is recalling 20 units of Multi-Unit Abutments because they are unable to accept the final abutment screw.
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. The defect prevents the device from functioning as intended (accepting the screw), but the source text does not report any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.
Plain-English summary
Keystone Dental Inc is recalling 20 units of Multi-Unit Abutment Angled, 17°, 4mm Cuff 4.1/4.5mm TiLobe® Implants, Catalog Number 45324K. The recall is due to a defect where the abutments are unable to accept the final abutment screw.
The affected products are identified by Lot Number 33006 and have an expiry date of March 31, 2022. These devices are intended for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations, including cement-retained, screw-retained, or overdenture restorations.
The recall covers units distributed nationwide in the United States, specifically in the states of North Dakota, New Jersey, and Massachusetts. Healthcare providers and patients should stop using these specific abutments and contact Keystone Dental Inc for further instructions.
The recalled product
- Product
- Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: Use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or…
- Manufacturer
- Keystone Dental Inc
- Hazard
- Affected units
- 20
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)
- REF - 45324K Lot Number - 33006 Expiry Date - March 31
- 2022
Distribution
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