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

FDA Device Recall #Z-0608-2018 — Class II — June 20, 2017

Recall Summary

Recall Number Z-0608-2018
Classification Class II — Moderate risk
Date Initiated June 20, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Keystone Dental Inc
Location Burlington, MA
Product Type Devices
Quantity 20 units

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.

Reason for Recall

Abutments are unable to accept the final abutment screw

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from Keystone Dental Inc

Recall # Classification Product Date
Z-1063-2019 Class II Paltop 1.25 Hex Drivers, Long Part Number: 60... Feb 22, 2019
Z-1062-2019 Class II Paltop Fully Guided Surgical Kit- containing th... Feb 22, 2019
Z-1061-2019 Class II Paltop Premium Surgical Kit-containing the 1.25... Feb 22, 2019
Z-1064-2019 Class II Paltop 1.25 Hex Drivers, Short Part Number: ... Feb 22, 2019
Z-2162-2018 Class II Prima Plus ¿4.1 x 11.5mm Implant, Catalog Numbe... May 1, 2018

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.