The Recall Desk
HighFDA (Devices)·Z-1381-2020·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 source text does not report any illnesses or injuries, and the hazard is a functional defect in data accuracy rather than a direct physical injury risk, placing it at the maximum score of 3 for a theoretical or unreported harm scenario.

Plain-English summary

Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA474) in the size 4.1mm(D) x 7.5mm(P) x 4mm(H). The recall is limited to Lot Number 1228899. These 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.

The recall is being issued 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 affects the accuracy of the digital data generated from the device.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected abutments and contact Biomet 3i, LLC for further instructions on how to proceed.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 7.5MM(P) X 4MM(H) Reference Number: IEHA474
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implant Component
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: 1228899

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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