The Recall Desk
ModerateFDA (Devices)·Z-1368-2020·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, but the source text explicitly states no illnesses or injuries are reported. The hazard is a functional defect (data misalignment) rather than a direct physical injury risk, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA346) with dimensions 3.4mm(D) x 3.8mm(P) x 6mm(H). The recall affects Lot Number 1228247. These products were distributed nationwide and in several foreign countries, including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK.

The recall was initiated 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 may affect the accuracy of the final dental restoration.

Dental professionals and patients should contact Biomet 3i for instructions on how to handle the affected units. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H) Reference Number: IEHA346
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: 1228247

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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