The Recall Desk
HighFDA (Devices)·Z-1370-2020·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.

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 causes significant functional errors (30-degree rotation and margin misalignment) in a medical device, 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: IEHA354) with dimensions 3.4mm(D) x 5mm(P) x 4mm(H). The affected lots are 1228687, 1229554, and 1229555. The product was distributed nationwide and in several foreign countries, including Australia, Austria, Belgium, China, France, Germany, Italy, Japan, the Netherlands, Poland, Spain, and the UK.

The recall was initiated because the impression or scanned data produced from these specific healing abutment lots results in an incorrect rotation of approximately 30 degrees and/or margin contour misalignment. This defect affects the accuracy of the data used for dental restorations.

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 agency has classified this as a Class II recall.

The recalled product

Product
CERTAIN BELLATEK ENCODE HEALING ABUTMENT 3.4MM(D) X 5MM(P) X 4MM(H) Reference Number: IEHA354
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 (3)

  • Lot Numbers: 1228687
  • 1229554
  • 1229555

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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