Recall Z-1215-2014— Biomet 3i, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet 3i, LLC, initiated 2013-08-26, terminated 2014-09-26. It names 2 FDA 510(k) clearances: K052648, K032263. 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.. Reason: Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received..
- Recalling firm
- Biomet 3i, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-26
- Terminated
- 2014-09-26
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K052648 — MODIFICATION TO 3I PATIENT-SPECIFIC DENTAL ABUTMENTS AND OVERDENTURE BARS
- K032263 — 3I PATIENT-SPECIFIC DENTAL ABUTMENT AND OVERDENTURE BAR
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.