The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-2512-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Unsealed Pouches

Biomet 3i, LLC is recalling certain Bellatek Encode Healing Abutment dental implants 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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class II, but the hazard is a packaging defect (unsealed pouches) with no reported injuries or illnesses, fitting the criteria for a Low severity score (packaging-only problems).

Plain-English summary

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

The affected products 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 are identified by codes such as IEHA343, IEHA344, and IEHA346, among others.

Consumers and healthcare providers should check their inventory for the specific product codes listed in the recall notice. If the products are found, they should be removed from use and returned to the manufacturer or their authorized distributor.

The recalled product

Product
Certain 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: IEHA343
  • IEHA344
  • IEHA346
  • IEHA348
  • IEHA353
  • IEHA354
  • IEHA356
  • IEHA358
  • IEHA443
  • IEHA444
  • IEHA446
  • IEHA448
  • IEHA453
  • IEHA454
  • IEHA456
  • IEHA458
  • IEHA463
  • IEHA464
  • IEHA466
  • IEHA468

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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