The Recall Desk
ModerateFDA (Devices)·Z-2496-2016·Announced 2016-08-24

Biomet 3i Recalls Straight Healing Abutment Dental Implants Due to Sealing Defects

Biomet 3i is recalling 1.6 million Straight Healing Abutment dental implants because pouches may not have been sealed during packing.

What this means for you

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) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling approximately 1,648,273 Straight 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. Specific item codes subject to the recall include ISMHA32, ISMHA33, ISMHA34, ISMHA36, ISHA46, ISHA48, ISWHA52, ISWHA53, ISWHA54, ISWHA56, ISWHA58, ISWHA62, ISWHA63, ISWHA64, ISWHA66, and ISWHA68.

The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should contact Biomet 3i for further instructions regarding the return or replacement of these devices.

The recalled product

Product
Certain Straight 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 (15)

  • Items: ISMHA32
  • ISMHA33
  • ISMHA34
  • ISMHA36
  • ISHA46
  • ISHA48
  • ISWHA52
  • ISWHA53
  • ISWHA54
  • ISWHA56
  • ISWHA58
  • ISWHA62
  • ISWHA63
  • ISWHA64
  • ISWHA66 and ISWHA68.

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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