The Recall Desk
HighFDA (Devices)·Z-1378-2020·Announced 2020-03-04

Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Data Errors

Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they produce incorrect rotation and margin contour data during scanning.

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 the defect involves significant data misalignment (30-degree rotation) that poses a risk of harm to the patient, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (4.1mm diameter x 6mm platform x 3mm height, Reference Number IEHA463). The recall affects Lot Number 1228840. The product was distributed nationwide and in several foreign countries, including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, the Netherlands, Poland, Spain, and the UK.

The recall was initiated because the resulting impression or scanned data produced from these specific healing abutment lots results in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect is a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

Dental professionals and patients who have used or are using these specific abutments should contact their healthcare provider or Biomet 3i for further instructions on how to proceed with their treatment.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA463
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: 1228840

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 →

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