The Recall Desk
ModerateFDA (Devices)·Z-1377-2020·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.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a temporary or medically reversible adverse health consequence. The defect causes data misalignment rather than direct physical injury, fitting the Moderate severity criteria for low-risk contamination or labeling/data errors.

Plain-English summary

Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA456) under FDA recall number Z-1377-2020. The affected product is a 4.1mm diameter x 5mm platform x 6mm height healing abutment, specifically from Lot Number 1229560.

The recall is issued because the impression or scanned data produced from these specific abutment lots results in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect affects the accuracy of the data used for dental restorations.

The affected units were distributed nationwide and in foreign countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK. Healthcare providers and patients should contact Biomet 3i for further instructions regarding the replacement or management of these devices.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 5MM(P) X 6MM(H) Reference Number: IEHA456
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
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: 1229560

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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