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

FDA device recall Z-1215-2014 · posted 2014-03-17 · Terminated

Recall details

Recalling firm

Biomet 3i, LLC

Reason for recall

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

Action taken

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

Status

Terminated

Product code

NHA

Quantity affected

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,

Date initiated

2013-08-26

Date posted

2014-03-17

Date terminated

2014-09-26

Location

Palm Beach Gardens, FL

Related 510(k) clearances