FDA Device recall Z-0299-2017
Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm
- FDA Device
- Class II
- terminated
- Published 2016-11-02
On 2016-11-02 the FDA classified a Class II recall of Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm by Keystone Dental, citing small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0299-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-15 |
| Published | 2016-11-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Keystone Dental |
| Distribution | US |
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
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Identifiers
| code_info | Lot # 27714 |
|---|
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-0299-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.