The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2510-2016·Announced 2016-08-24

Biomet 3i Recalls Bellatek Encode Healing Abutments Due to Sealing Defects

Biomet 3i is recalling 1.6 million Bellatek Encode Healing Abutments because pouches may not have been sealed during packing.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries.

Plain-English summary

Biomet 3i, LLC is recalling approximately 1,648,273 Bellatek Encode Healing Abutment dental implants. The recall was initiated because the product pouches may not have been sealed during the packing process.

The affected devices were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries. The specific items subject to the recall include various EHA series codes, such as EHA343, EHA344, and EHA346.

Consumers and healthcare providers should stop using the affected devices and contact Biomet 3i for further instructions on how to return or replace the products.

The recalled product

Product
Bellatek Encode Healing Abutment Dental implants
Manufacturer
Biomet 3i, LLC
Category
Medical Device — Dental Implants
Hazard
Affected units
1,648,273

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 (20)

  • Items: EHA343
  • EHA344
  • EHA346
  • EHA348
  • EHA353
  • EHA354
  • EHA356
  • EHA358
  • EHA443
  • EHA444
  • EHA446
  • EHA448
  • EHA453
  • EHA454
  • EHA456
  • EHA458
  • EHA463
  • EHA464
  • EHA466
  • EHA468

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 119 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 119 products in this recall →

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