The Recall Desk
HighFDA (Devices)·Z-1373-2020·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 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. The hazard involves a functional defect (rotation error and misalignment) in a medical device that could lead to improper dental treatment, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutments (Reference Number: IEHA444) with dimensions 4.1mm(D) x 4.1mm(P) x 4mm(H). The affected lots are 1228625 and 1229564. The recall is classified as Class II by the U.S. Food and Drug Administration.

The recall is being issued because the resulting impression or scanned data produced from these specific healing abutment lots will result in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect affects the accuracy of the dental work performed using these components.

The product was distributed nationwide and in foreign countries including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, Netherlands, Poland, Spain, and the UK. Consumers and healthcare providers 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 4.1MM(P) X 4MM(H) Reference Number: IEHA444
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Abutments
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 (2)

  • Lot Numbers: 1228625
  • 1229564

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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