Z-2594-2014Class II

BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments...

Name: Z-2594-2014 BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments...
Creator: Biomet 3i, LLC
Published: 2014-06-25
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2014-06-25 / Terminated / root cause: labeling and UDI

FDA source

Biomet 3i, LLC began a recall of BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening... on 2014-06-25. FDA classified it as Class II and gives the reason as "Identifiers on the label are correct but the label has the incorrect color coding". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2594-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-25
Posted: 2014-09-05
Terminated: 2014-09-23
Recalling firm: ZimVie US Corp LLC
Product: BIOMET 3i Certain Bellatek Encode Healing Abutment Biomet 3i Healing abutments are temporary abutments indicated for use in maintaining the soft tissue opening throughout the healing process prior to dental restoration.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Identifiers on the label are correct but the label has the incorrect color coding.
Root cause tag: labeling and UDI
FDA root cause: Mixed-up of materials/components
Action: Biomet 3i sent an Urgent - Medical Device Removal letter / and by phone call on and dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action to be taken by the customer. If you have any Certain BellaTek Encode Healing Abutment(s) of the affected lot in your practice, please return the abutment(s) to BIOMET 3i in exchange for Cettain BellaTek Encode Healing Abutments, IEHA458 with a proper color stripe. Alternatively, you may return the Certain BellaTek Healing Abutment(s) for full credit. We also ask that you confirm receipt of this notification by completing the attached Recall Return Response Form, indicating your preference for replacement or credit and/ or notifying us if the product was used. Thank you for your support - we are committed to maintaining high standards of quality for all our products and apologize for any inconvenience this may have caused you. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.
Quantity in commerce: 6 units
Distribution: US Distribution to NH and TX.
Product codes and lots: Model Number IEHA458, Lot number: 1167545.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2594-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2594-2014	Class II	Terminated	Voluntary: Firm initiated	2014-09-17	2014-09-05

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)