Z-1215-2014Class II

Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ...

Name: Z-1215-2014 Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ...
Creator: Biomet 3i, LLC
Published: 2013-08-26
License: https://open.fda.gov/license/

ZimVie US Corp LLC / initiated 2013-08-26 / Terminated / root cause: design

FDA source

Biomet 3i, LLC began a recall of Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment... on 2013-08-26. FDA classified it as Class II and gives the reason as "Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received". 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-1215-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-26
Posted: 2014-03-17
Terminated: 2014-09-26
Recalling firm: ZimVie US Corp LLC
Product: Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses.
Product code: NHA Abutment, Implant, Dental, Endosseous
Reason for recall: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, BIOMET 3i, sent an "URGENT: Medical Device Removal - BellaTek Zirconia Abutments" letter dated August 2013 via email, facsimile or postal mail to its customers. The letter described the product, problem and actions to be taken. All customers were instructed to check their inventory for the affected product; return the abutments to BIOMET 3i for replacement and full credit; complete and return the attached Recall Return Response Form, and to advise their customers and forward a copy of the Medical Device Removal Notice and the contained recommendations. BIOMET 3i has decided to initiate a design change to mitigate the fracture risk, and consequently, will cease distribution of BellaTek Zirconia Abutments unit l the corrective actions are completed. If you have any further questions, please contact Customer Service at 1-800-342-5454 for assistance.
Quantity in commerce: 10,454
Distribution: Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, Hawaii and Puerto Rico; and countries of: Spain, Australia, Canada, Colombia, Japan, Uruguay, Mexico, Estonia, United Kingdom, Denmark, Germany, Spain, Italy, Poland, Ireland Netherlands, France, Sweden, Portugal, Australia, France, Belgium, Switzerland, Norway, Czech Republic, France, Holland, and Luxembourg.
Product codes and lots: All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1215-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1215-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-17

Product code NHA

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)