FDA Device recall Z-1179-2018
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit
- FDA Device
- Class III
- terminated
- Published 2018-04-04
On 2018-04-04 the FDA classified a Class III recall of STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit by Keystone Dental, citing 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 abu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1179-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-10-16 |
| Published | 2018-04-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Keystone Dental |
| Distribution | n/a |
Product
STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit; Catalog Number: S2437-01-1K
Reason
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.
Identifiers
| code_info | Lots: 35026, 35579, 36133 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1179-2018%22
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