Keystone Dental product recalled over labeling errors

Recall date

August 25, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Keystone Dental Inc recalls Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partia…

Recall number

Z-0727-2018

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

Nationally.

Why it was recalled

The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stage-1¿ RDS Indexed Abutment for RDS Stage-1¿ Single Stage Implants Keystone s implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement retained, screw retained, or overdenture restorations and terminal or intermediate abutment support for fixed bridgework.