Recall Z-1818-2017— Keystone Dental Inc

Name: FDA recall Z-1818-2017
Creator: U.S. Food and Drug Administration
Published: 2017-03-09

Class II · Terminated

Class II FDA medical device recall by Keystone Dental Inc, initiated 2017-03-09, terminated 2017-07-05. It names one FDA 510(k) clearance: K051614. Product: Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K. Reason: Straight PrimaConnex Implants contained Tapered PrimaConnex Implants.

Recalling firm: Keystone Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2017-03-09
Terminated: 2017-07-05
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 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

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