Terminated

Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454EDAZ , EDAZx and ILDExxxBellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; PilarRx onlyNon-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.

FDA Recall Z-1215-2014 · Posted 2014-03-17

Recalling FirmBiomet 3i, LLC

Recall StatusTerminated

Product CodeNHA

Date Initiated2013-08-26

Date Terminated2014-09-26

Product Quantity10,454

Reason for Recall

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

Firm 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.

Root Cause

Device Design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K052648MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARSImplant Innovations, Inc. · 2005-10-20 K0322633I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BARImplant Innovations, Inc. · 2004-01-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.