Z-0029-05

EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the...

Name: Z-0029-05 EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the...
Creator: Implant Innovations, Inc.
Published: 2004-10-04
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2004-10-04 / Terminated / root cause: sterility

FDA source

Implant Innovations, Inc. began a recall of EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant on 2004-10-04. The reason FDA records is "The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0029-05
Status: Terminated
Initiated: 2004-10-04
Posted: 2004-10-21
Terminated: 2005-02-07
Recalling firm: ZimVie US Corp LLC
Product: EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.
Product code: DZE Implant, Endosseous, Root-Form
Reason for recall: The nylon bag holding the product was not completely sealed before sterilization. Patients could be infected if the abutment is implanted.
Root cause tag: sterility
FDA root cause: Other
Action: Begining on October 4, 2004 each direct account was contacted by email, faxed letter and telephone. They were informed of the recall and instructed to contact their customers if the product had been sold.
Quantity in commerce: 216 units
Distribution: Distributed to 34 direct accounts throughout the United States and four international accounts in Europe, Asia, South America and the middle East.
Product codes and lots: Product Code: THA54 Lot No. 249229

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)