Z-0811-2007

Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34...

Name: Z-0811-2007 Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34...
Creator: Biomet 3i
Published: 2007-04-25
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2007-04-25 / Terminated

FDA source

Biomet 3i began a recall of Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36 on 2007-04-25. The reason FDA records is "The Straight Healing Abutment did not fully seat to 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.

Recall record

Recall number: Z-0811-2007
Status: Terminated
Initiated: 2007-04-25
Posted: 2007-05-16
Terminated: 2008-11-18
Recalling firm: ZimVie US Corp LLC
Product: Certain MicroMiniplant Straight Healing Abutment. Dental implant. Model numbers: ISMHA32, ISMHA33, ISMHA34 and ISMHA36.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The Straight Healing Abutment did not fully seat to the restorative platform of the implant, leaving a gap between the abutment and the implant.
FDA root cause: Other
Action: Each consignee was notified on 4/25/2007 by telephone using a prepared script. A follow letter was sent by fax. Each consignee was instructed to check their respective inventory for the affected product and to return a response card and any affected product to the firm.
Quantity in commerce: 362 units
Distribution: Distributed worldwide, including USA, Spain and the Netherlands.
Product codes and lots: lot Numbers: 593025-5, 593027-5, 598408-5, 593028-5, 599866-5 and 593029-5.

Product code DZE

K934126Class IIOne and Two Piece Temporary Healing,(emergence Profile) AbutmentsImplant Innovations, Inc. / cleared 1994-04-25

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)