STAGE-1¿ RDS COC Abutment Plastic Sleeve — Class III medical device recall Z-1179-2018
Terminated recall by Keystone Dental Inc, reported 2018-04-04. A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of
| Recall number | Z-1179-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2017-10-16 |
| Classified | 2018-03-24 |
| Reported by FDA | 2018-04-04 |
| Terminated | 2019-04-17 |
| Countries outside the US | DE |
| Quantity | 55 |
| Lot numbers | 35026, 35579, 36133 |
| Model numbers | S2437-01-1K |
Product
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Reason for recall
A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
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-1179-2018. 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.