device · product 1 of 1
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.
- Recall number
- Z-1215-2014
- Initiated
- August 26, 2013
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Biomet 3i, LLC
- Quantity
- 10,454
App-derived interpretation
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Official device-enrichment evidence · Sourced
Device Design
Inspect official wording and provenance
Reason for recall
Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.
Code information
All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx
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.