The Recall Desk
HighFDA (Devices)·Z-1374-2020·Announced 2020-03-04

Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Fit Issues

Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may cause incorrect rotation and margin misalignment.

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. The hazard involves a functional defect (rotation and misalignment) that could compromise the fit of a medical device, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments (4.1mm diameter x 4.1mm platform x 6mm height, Reference Number IEHA446). The recall is limited to units with Lot Number 1228703.

The FDA has classified this as a Class II recall. The identified issue is that impressions or scanned data produced from these specific healing abutments may result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect could affect the accuracy of the final dental restoration.

The affected products were distributed nationwide and in several foreign countries, including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, the Netherlands, Poland, Spain, and the UK. Healthcare professionals and patients who have used or are using these specific abutments should contact Biomet 3i or their dental provider for further instructions on replacement or corrective action.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 4.1MM(P) X 6MM(H) Reference Number: IEHA446
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant Components
Hazard

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 (1)

  • Lot Numbers: 1228703

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 23 recalled by Biomet 3i, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 23 products in this recall →

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · misalignment

See all →