Primaconnex Internal Connection Implant System, Primaconnex Internal Connection Prosthetics

• • Terminated Z-2162-2018 FDA Class II ·initiated 1 May 2018

  The implants are mislabeled.

• • Terminated Z-0608-2018 FDA Class II ·initiated 20 Jun 2017 ·on shared 510(k) K051614

  Abutments are unable to accept the final abutment screw

• • Terminated Z-1818-2017 FDA Class II ·initiated 9 Mar 2017

  Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

• • Terminated Z-0299-2017 FDA Class II ·initiated 15 Sep 2016

  Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)

• • Terminated Z-0973-2013 FDA Class II ·initiated 11 Mar 2013 ·on shared 510(k) K051614

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K051614 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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