Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants… — Class II medical device recall Z-0727-2018
Terminated recall by Keystone Dental Inc, reported 2018-03-07. The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label
| Recall number | Z-0727-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2017-08-25 |
| Classified | 2018-02-27 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2019-04-16 |
| Quantity | 20 |
| Reason classes | labeling |
| Lot numbers | 34276 |
| Model numbers | S2400K |
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 overdenture restorations and terminal or intermediate abutment support for fixed bridgework.
Reason for recall
The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0727-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.