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Keystone Dental Inc recalls Keystone Dental PrimaConnex¿ Straight Implant TC, RD Internal Connection 4.0 x 11.5mm. Product code:15613K Implants ar
Recalled November 2, 2016 · FDA recall Z-0299-2017 · Keystone Dental
Hazard
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD) · FDA Class II
Units
55 units
Sold at
Worldwide distribution - US (Nationwide Distribution to CA, CO, IL, MA, MN, ND, NY, NV, PA, and VA.) and Italy
Description
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Product
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
Manufacturer(s)
Keystone Dental Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →