The Recall Desk
ModerateFDA (Devices)·Z-2465-2016·Announced 2016-08-24

Biomet 3i Recalls Gingihue Post Dental Implants Due to Sealing Defects

Biomet 3i is recalling Gingihue Post 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 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 Gingihue Post Dental implants due to a manufacturing defect where pouches may not have been sealed during packing. The recall covers 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The specific hazard is that the packaging may not be sealed, which could affect the sterility of the dental implants. The affected product codes include MAP32G, MAP34G, APP462G, APP464G, APP472G, APP474G, WPP554G, WPP562G, WPP564G, WPP572G, WPP574G, WPP662G, WPP664G, WPP672G, and WPP674G.

Healthcare providers and consumers should check their inventory for these specific product codes and stop using the affected devices. They should contact Biomet 3i, LLC for instructions on how to return or dispose of the recalled products.

The recalled product

Product
Gingihue Post 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 (14)

  • Items: MAP32G
  • MAP34G
  • APP462G
  • APP464G
  • APP472G
  • APP474G
  • WPP554G
  • WPP562G
  • WPP564G
  • WPP572G
  • WPP574G
  • WPP662G
  • WPP664G
  • WPP672G and WPP674G.

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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