Z-0922-2007

EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an...

Name: Z-0922-2007 EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an...
Creator: Biomet 3i
Published: 2006-10-16
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2006-10-16 / Terminated / root cause: packaging

FDA source

Biomet 3i began a recall of EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant on 2006-10-16. The reason FDA records is "Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0922-2007
Status: Terminated
Initiated: 2006-10-16
Posted: 2007-06-14
Terminated: 2008-12-30
Recalling firm: ZimVie US Corp LLC
Product: EP Healing abutment- Product Code-ITHA52-a pre-manufactured prosthetic component directly connected to an endosseous dental implant.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: Package Integrity; sterility compromised-Incomplete seals on the nylon bags in which the product is packed.
Root cause tag: packaging
FDA root cause: Other
Action: Each consignee will be contacted by email or telephone followed by a faxed letter. Each consignee was instructed to check their respective inventory for the recalled part and corresponding lot number. They were directed to return the product to the recalling firm.
Distribution: Worldwide.
Product codes and lots: Lot Number: 560988

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)