Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 t — recall Z-0608-2018

U.S. FDA — Device Enforcement · United States · 2017-06-20 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0608-2018
Date of alert: 2017-06-20
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Keystone Dental Inc
Product category: device
Product type: Devices

Reported risk: Abutments are unable to accept the final abutment screw

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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