Home / Recalls / Biomet 3I, LLC / Z-1215-2014

Z-1215-2014 Class II Terminated

Recalled by Biomet 3I, LLC — Palm Beach Gardens, FL

FDA device recall Z-1215-2014 was initiated by Biomet 3I, LLC on Aug 26, 2013 and is designated Class II. Reason for recall: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. The recall status is terminated (terminated Sep 26, 2014). Affected quantity: 10,454.

Recall Details

Product Type: Devices
Report Date: Mar 26, 2014
Initiation Date: Aug 26, 2013
Termination Date: Sep 26, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,454

Product Description

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.

Reason for Recall

Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.

Distribution Pattern

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.

Code Information

All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1215-2014
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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