The Recall Desk
HighFDA (Devices)·Z-1369-2020·Announced 2020-03-04

Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Misalignment

Biomet 3i, LLC is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation or margin contour misalignment in dental impressions.

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 hazard involves a risk of harm (incorrect dental restoration) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments, specifically the 3.4mm(D) x 5mm(P) x 3mm(H) size with Reference Number IEHA353. The recall is limited to Lot Number 1228667.

The FDA has classified this as a Class II recall. The defect involves the resulting impression or scanned data produced from these abutments, which may result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This issue could affect the accuracy of dental restorations created using these components.

The affected 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. Consumers and dental professionals should stop using the affected abutments and contact Biomet 3i, LLC for instructions on how to return the product or obtain a replacement.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 3MM(H) Reference Number: IEHA353
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: 1228667

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

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Same hazard · misalignment

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