The Recall Desk
HighFDA (Devices)·Z-1383-2020·Announced 2020-03-04

Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Rotation Error

Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and 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 defect involves a significant functional error (30-degree rotation) in a medical device that could lead to improper dental restorations, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA554) with lot numbers 1228904 and 1230638. The recall is due to a defect where the resulting impression or scanned data produced from these abutments may result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment.

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. The agency has classified this as a Class II recall.

Dental professionals should stop using the affected lots and contact Biomet 3i for further instructions. Patients who have had dental work performed using these specific abutments should consult their dental provider to determine if their restoration requires adjustment or replacement.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 5.6MM(P) X 4MM(H) Reference Number: IEHA554
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: 1228904 1230638

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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Same hazard · misalignment

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