Keystone Dental Inc: Medical Device Recall in 2018 - (Recall #: Z-0608-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.
Product Description:

Multi-Unit Abutment Angled, 17¿, 4mm Cuff 4.1/4.5mm TiLobe¿ Implants, Catalog Number 45324K pRODUCT Usage: 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.

Product Classification:

Class II

Date Initiated: June 20, 2017
Date Posted: February 21, 2018
Recall Number: Z-0608-2018
Event ID: 79040
Reason for Recall:

Abutments are unable to accept the final abutment screw

Status: Terminated
Product Quantity: 20 units
Code Information:

REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022

Distribution Pattern:

US Nationwide Distribution in the states of ND, NJ & MA

Voluntary or Mandated:

Voluntary: Firm initiated