Recall Z-0973-2013— Keystone Dental Inc

Name: FDA recall Z-0973-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-11

Class II · Terminated

Class II FDA medical device recall by Keystone Dental Inc, initiated 2013-03-11, terminated 2013-09-26. It names one FDA 510(k) clearance: K051614. Product: PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.. Reason: Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled.

Recalling firm: Keystone Dental Inc
Classification: Class II
Status: Terminated
Initiated: 2013-03-11
Terminated: 2013-09-26
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

PrimaConnex Tapered Implant TC, SD Internal Connection 3.5 x 10mm Catalog Number: l5613K. Implants in support for fixed bridgework.

Reason for recall

Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

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