Biomet 3i Recalls Certain Gingihue Post Dental Implants
Biomet 3i, LLC is recalling specific Gingihue 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. The hazard involves potential packaging failure (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria for minor labeling or packaging errors.
Plain-English summary
Biomet 3i, LLC is recalling certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) dental implants, item IWPP552G. The recall involves 1,648,273 units distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as numerous foreign countries.
The reason for the recall is that pouches containing the implants may not have been sealed during packing. The affected lots are 1147381, 1153937, and 1153938.
Consumers and healthcare providers should stop using the affected products and contact Biomet 3i, LLC for further instructions.
The recalled product
- Product
- Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G 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 (3)
- Lot # 1147381
- 1153937
- and 1153938
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.
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