Keystone Dental Inc: Medical Device Recall in 2016 - (Recall #: Z-0299-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: September 15, 2016

Date Posted: November 2, 2016

Recall Number: Z-0299-2017

Event ID: 75224

Reason for Recall:

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

Status: Terminated

Product Quantity: 55 units

Code Information:

Lot # 27714

Distribution Pattern:

Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy

Voluntary or Mandated:

Voluntary: Firm initiated