Reported Feb 21, 2018 · Terminated

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

Keystone Dental Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Keystone Dental Inc · 154 Middlesex Tpke · Burlington, MA · 01803-4403

Is this the product you have?

    • Multi-Unit Abutment Angled
    • 17¿
    • 4mm Cuff 4.1/4.5mm TiLobe¿ Implants
  • Catalog Number 45324K pRODUCT UsageUse 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
Lot codes and dates
  • REF - 45324K Lot Number - 33006 Expiry Date - March 31, 2022
Amount recalled
20 units

Where it was sold

Why it was recalled

Abutments are unable to accept the final abutment screw

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 9, 2018 · Data as of Sep 19, 5:27 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.