Biomet 3i Recalls Gingihue Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling Gingihue 15-degree angled post dental implants because pouches may not have been sealed during packing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 voluntary precautionary issue without reported injuries.
Plain-English summary
Biomet 3i, LLC is recalling certain Gingihue 15-degree angled post dental implants. The recall is being conducted because the pouches containing the devices may not have been sealed during the packing process.
The recall involves 1,648,273 devices. These products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries. The specific item code for the affected products is IMPAP34G.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Certain Gingihue TM 15 degree Angled Post Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- 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 (1)
- Item: IMPAP34G
Distribution
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 →- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- HighBiomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls Misaligned BellaTek Dental Abutments
FDA (Devices) · 2020-10-14
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- LowBiomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Low Profile Dental Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- ModerateBiomet 3i Dental Implant Abutments Recalled for Unsealed Packaging
FDA (Devices) · 2016-12-28
- LowBiomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
FDA (Devices) · 2016-12-28
- LowBiomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Dental Implant Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28