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Keystone Dental Inc recalls Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or
Recalled June 20, 2018 · FDA recall Z-2162-2018 · Keystone Dental
Hazard
The implants are mislabeled. · FDA Class II
Units
72
Sold at
US Distribution to the states of : CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, and VA.
Description
The implants are mislabeled.
Product
Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
Manufacturer(s)
Keystone Dental Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →