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Terminated

BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X 2mm(H), BioMet 3i, Palm Gardens, FL.

FDA Recall Z-1365-2008 · Posted 2008-03-28

Recalling FirmBiomet 3i, Inc.
Recall StatusTerminated
Product CodeNHA
Date Initiated2008-02-06
Date Terminated2008-07-07
Product Quantity270

Reason for Recall

Seating Problems: The Micro-miniplant Straight Healing Abutments do not fully seat onto the restorative platform of the implant leaving a gap between the abutment and the implant.

Firm Action

USA customers were contacted by telephone with a follow-up fax. International customers were first contacted by E-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i.

Root Cause

Device Design

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K072642BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTSBiomet 3i, Inc. · 2007-12-20

Official Source

View FDA Recall →

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

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