Multi-Unit Abutment Angled — Class II medical device recall Z-0608-2018
Terminated recall by Keystone Dental Inc, reported 2018-02-21, distributed nationwide. Abutments are unable to accept the final abutment screw
| Recall number | Z-0608-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2017-06-20 |
| Classified | 2018-02-13 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-04-09 |
| Distributed | Nationwide (US) |
| Quantity | 20 units |
| Lot numbers | 33006 |
| Model numbers | 45324K |
| Expiration dates | 2022-03-31 |
Product
Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: 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
Abutments are unable to accept the final abutment screw
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-0608-2018. 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.