Drug recall
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
FDA recall event 79297 · Class III · Keystone Dental Inc
Key facts
| Event ID | 79297 |
|---|---|
| Recall numbers | Z-1179-2018 |
| Recalling firm | Keystone Dental Inc |
| Product type | Devices |
| Products | STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Oct 16, 2017 |
| Report date | Apr 4, 2018 |
| Termination date | Apr 17, 2019 |
| City | Burlington |
| State | MA |
| Country | United States |
| FEI number | 3005990499 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: