The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1384-2020·Announced 2020-03-04

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

Biomet 3i is recalling specific Bellatek Encode Healing Abutments because they may produce incorrect rotation and margin contour misalignment in scanned data.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 significant functional errors (30-degree rotation and margin misalignment) in a medical device, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Biomet 3i, LLC is voluntarily recalling certain Bellatek Encode Healing Abutments (5mm(D) x 6mm(P) x 3mm(H), Reference Number IEHA563). The recall affects lot numbers 1228593 and 1230791. These 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.

The FDA has classified this as a Class II recall. The issue is that 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 may affect the accuracy of dental restorations created using the scanned data.

Dental professionals and patients who have used or may have used these specific lots should contact Biomet 3i, LLC for further instructions on how to proceed. The company is the recalling firm and is responsible for managing the recall process.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 5MM(D) X 6MM(P) X 3MM(H) Reference Number: IEHA563
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 (1)

  • Lot Numbers: 1228593 1230791

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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