The Recall Desk
ModerateFDA (Devices)·Z-2524-2016·Announced 2016-08-24

Biomet 3i Recalls Certain Gingihue 15 Degree Angled Post Dental Implants

Biomet 3i is recalling specific Gingihue 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) which is a low-risk contamination or labeling/packaging issue without reported injuries.

Plain-English summary

Biomet 3i, LLC is recalling certain Gingihue 15 degree Angled Post Dental implants. The recall involves 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The reason for the recall is that pouches containing the implants may not have been sealed during packing. The affected items include specific codes such as IPAP464G, IPAP472G, IPAP474G, IPAP462G, IPAP554G, IPAP562G, IPAP564G, IPAP572G, IPAP574G, IPAP662G, IPAP664G, IPAP672G, and IPAP674G.

Consumers and healthcare providers should check their inventory for these specific product codes and contact Biomet 3i for further instructions on how to handle the recalled devices.

The recalled product

Product
Certain Gingihue 15 degree 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 (12)

  • Items: IPAP464G
  • IPAP472G
  • IPAP474G
  • IPAP462G
  • IPAP554G
  • IPAP562G
  • IPAP564G
  • IPAP572G
  • IPAP574G
  • IPAP662G
  • IPAP664G
  • IPAP672G AND IPAP674G.

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 →