The Recall Desk
HighFDA (Devices)·Z-1215-2014·Announced 2014-03-26

Biomet 3i Recalls BellaTek Zirconia Dental Abutments Due to Fracture Reports

Biomet 3i is recalling BellaTek Zirconia Dental Abutments because of reports of fractures. The recall covers 10,454 units distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (fracture) where specific injury reports are not detailed in the source text, fitting the High severity criteria.

Plain-English summary

Biomet 3i, LLC is recalling BellaTek Zirconia Dental Abutments due to reports of product fractures. The affected products are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients.

The recall includes 10,454 units of catalog models EDAZ, EDAZx, and ILDExxx. These products were manufactured since April 1, 2011, and were distributed nationwide in the United States and in numerous countries including Spain, Australia, Canada, and the United Kingdom.

Dental professionals and patients should stop using the affected abutments and contact Biomet 3i for further instructions. The company is the recalling firm for this action.

The recalled product

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 us
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant Components
Hazard
Affected units
10,454

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

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