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Terminated

CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM, Item Number IIAT3 - Product Usage: BIOMET3i Restorative products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible

FDA Recall Z-2142-2019 · Posted None

Recalling FirmBiomet 3i, LLC
Recall StatusTerminated
Product CodeNHA
Date Initiated2019-02-26
Date Terminated2020-06-15
Product Quantity6 units

Reason for Recall

During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.

Firm Action

The firm disseminated the notices by email on 02/26/2019. The letter requested that the dental laboratories quarantine and return any unused product and to further notify the affected clinician referral.

Root Cause

Process control

Distribution Pattern

Nationwide and Puerto Rico, Canada, and Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102209ENCODE PATIENT SPECIFIC ABUTMENTBiomet 3i, Inc. · 2010-12-03K052648MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARSImplant Innovations, Inc. · 2005-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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