Z-0727-2018 Class II Terminated

Recalled by Keystone Dental Inc — Burlington, MA

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
August 25, 2017
Termination Date
April 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20

Product Description

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.

Reason for Recall

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.

Distribution Pattern

Nationally.

Code Information

Catalog# S2400K, Lot 34276