Z-1365-2008

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

Name: Z-1365-2008 BIOMET 3i Certain MicroMiniplant Straight Healing Abutment, Model/Item Number: ISMHA32, 3.4mm(D) X 0mm(P) X...
Creator: Biomet 3i, Inc.
Published: 2008-02-06
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2008-02-06 / Terminated / root cause: design

FDA source

Biomet 3i, Inc. began a recall of 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 on 2008-02-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1365-2008
Status: Terminated
Initiated: 2008-02-06
Posted: 2008-03-28
Terminated: 2008-07-07
Recalling firm: ZimVie US Corp LLC
Product: 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.
Product code: NHA Abutment, Implant, Dental, Endosseous
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 270
Distribution: Worldwide
Product codes and lots: Lot Number: 593025-5

Product code NHA

K072642Class IIBiomet 3I Dental Abutments and Restorative ComponentsBiomet 3i, Inc. / cleared 2007-12-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)