medical Class II Updated 2018-06-20

Keystone Dental Inc recalls Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K K

Recalled 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.

Hazard / Issue

The implants are mislabeled.

Issued by

FDA

Affected States: CA, CT, FL, IN, MA, MD, MI, MN, MT, NJ, NV, NY, TX, VA
Lot/Code Info: UDI: D76815737K0, Lot 37038
View official government recall

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