The Recall Desk
ModerateFDA (Devices)·Z-2463-2016·Announced 2016-08-24

Biomet 3i EP Healing Abutment Dental Implants Recalled for Unsealed Pouches

Biomet 3i is recalling EP Healing Abutment dental implants because pouches may not have been sealed during packing, potentially compromising sterility.

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 is a potential sterility issue due to unsealed packaging. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling EP Healing Abutment dental implants. The recall is due to a manufacturing issue where pouches may not have been sealed during packing. This defect could potentially affect the sterility of the devices.

The recall involves 1,648,273 devices. The products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. Specific item codes affected include MHA32, MHA33, MHA34, MHA36, THA58, THA63, THA64, THA66, THA68, THA73, THA74, THA76, THA78, WTH52, WTH53, WTH54, WTH56, WTH58, WTH562, WTH563, WTH564, WTH566, WTH568, WTH572, WTH573, WTH574, WTH576, WTH578, WTH62, WTH63, WTH64, WTH66, WTH68, WTH672, WTH673, WTH674, WTH676, and WTH678.

Healthcare providers and consumers should stop using these devices and contact Biomet 3i, LLC for further instructions or a replacement.

The recalled product

Product
EP 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: MHA32
  • MHA33
  • MHA34
  • MHA36
  • THA58
  • THA63
  • THA64
  • THA66
  • THA68
  • THA73
  • THA74
  • THA76
  • THA78
  • WTH52
  • WTH53
  • WTH54
  • WTH56
  • WTH58
  • WTH562
  • WTH563

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 →

Related recalls

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Same hazard · sterility

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