The Recall Desk
ModerateFDA (Devices)·Z-1380-2020·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

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. The hazard involves data inaccuracy (rotation and contour misalignment) rather than direct physical injury or contamination, fitting the criteria for moderate severity involving functional defects without reported harm.

Plain-English summary

Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA466). The affected product is a 4.1mm diameter x 6mm platform x 6mm height healing abutment. The recall covers Lot Number 1228704.

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 affects the accuracy of the digital data used for dental procedures.

The affected products were distributed nationwide and in foreign countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK. Consumers and dental professionals should stop using the affected lots and contact Biomet 3i for further instructions.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 4.1MM(D) X 6MM(P) X 6MM(H) Reference Number: IEHA466
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: 1228704

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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