The Recall Desk
ModerateFDA (Devices)·Z-2464-2016·Announced 2016-08-24

Biomet 3i Recalls Gingihue Dental Implants Due to Unsealed Pouches

Biomet 3i is recalling Gingihue 15 Degree Pre-Angled Post 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The hazard is a packaging defect (unsealed pouches) rather than a direct structural failure or reported injury, fitting the Moderate severity criteria for low-risk contamination or packaging issues.

Plain-English summary

Biomet 3i, LLC is recalling Gingihue 15 Degree Pre-Angled Post Dental implants. The recall involves 1,648,273 devices distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands.

The reason for the recall is that pouches may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the dental implants.

Affected items include specific codes such as MPAP32G, MPAP34G, PAP454G, PAP462G, PAP464G, PAP472G, PAP474G, PAP552G, PAP554G, PAP562G, PAP564G, PAP572G, PAP574G, PAP662G, PAP664G, PAP672G, and PAP674G. Healthcare providers and consumers should contact Biomet 3i, LLC for further instructions on how to handle these devices.

The recalled product

Product
Gingihue 15 Degree Pre-Angled 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 (16)

  • Items: MPAP32G
  • MPAP34G
  • PAP454G
  • PAP462G
  • PAP464G
  • PAP472G
  • PAP474G
  • PAP552G
  • PAP554G
  • PAP562G
  • PAP564G
  • PAP572G
  • PAP574G
  • PAP662G
  • PAP664G
  • PAP672G and PAP674G.

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

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · packaging defect

See all →