Recall Z-0299-2017— Keystone Dental Inc

Name: FDA recall Z-0299-2017
Creator: U.S. Food and Drug Administration
Published: 2016-09-15

Class II · Terminated

Class II FDA medical device recall by Keystone Dental Inc, initiated 2016-09-15, terminated 2017-01-03. It names one FDA 510(k) clearance: K051614. 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).

Recalling firm: Keystone Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2016-09-15
Terminated: 2017-01-03
Firm location: Burlington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K051614 — PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICSLifecore Biomedical, Inc.·cleared 2005-09-09

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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)

Data sourced from openFDA. This site is unofficial and independent of the FDA.