Keystone Dental Recalls Mislabeled Stage-1 RDS Indexed Abutments
Keystone Dental Inc is recalling 20 Stage-1 RDS Indexed Abutments because the expiration date on the label is incorrect.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and labeling error (incorrect expiration date) without reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Keystone Dental Inc is recalling 20 units of Stage-1 RDS Indexed Abutments for RDS Stage-1 Single Stage Implants. The product is distributed nationally. The specific units affected are identified by Catalog# S2400K and Lot 34276.
The recall was initiated because the units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06, whereas the correct expiration date is 2022-06.
These implants are intended for use in partially or fully edentulous mandibles and maxillae to support single or multiple-unit restorations. Consumers and healthcare providers should stop using the affected units and contact Keystone Dental Inc for further instructions.
The recalled product
- Product
- Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for 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
- Category
- Medical Device — Dental Implants
- 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)
- Catalog# S2400K
- Lot 34276
Distribution
Distribution scope not specified by the agency.
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