Keystone Dental Inc — Class II medical device recall Z-1818-2017
Terminated recall by Keystone Dental Inc, reported 2017-04-19, distributed in CA, FL, IL, IN, MA, MN, NJ, NV…. Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
| Recall number | Z-1818-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2017-03-09 |
| Classified | 2017-04-13 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-07-05 |
| Distributed | CA, FL, IL, IN, MA, MN, NJ, NV, PA |
| Quantity | 59 units |
| Lot numbers | 30214 |
| Model numbers | 15636K |
Product
Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
Reason for recall
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
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-1818-2017. 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.