Recall Z-2162-2018— Keystone Dental Inc

Name: FDA recall Z-2162-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-01

Class II · Terminated

Class II FDA medical device recall by Keystone Dental Inc, initiated 2018-05-01, terminated 2018-09-14. It names one FDA 510(k) clearance: K051614. Product: Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.. Reason: The implants are mislabeled..

Recalling firm: Keystone Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-01
Terminated: 2018-09-14
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

Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

Reason for recall

The implants are mislabeled.

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