Keystone Dental PrimaConnex¿ Straight Implant TC — Class II medical device recall Z-0299-2017
Terminated recall by Keystone Dental Inc, reported 2016-11-02, distributed nationwide. Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant di
| Recall number | Z-0299-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2016-09-15 |
| Classified | 2016-10-21 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-01-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| Quantity | 55 units |
| Lot numbers | 27714 |
Product
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations includ-ing; cement retained, screw retained, or overdenture restorations and terminal or inter-mediate abutment support for fixed bridgework
Reason for recall
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
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-0299-2017. 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.