Biomet 3i Recalls Certain Gingihue Post Dental Implants
Biomet 3i is recalling certain Gingihue 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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a packaging-only problem (unsealed pouches) with no reported illnesses or injuries, fitting the 'Low' severity criteria for cosmetic or packaging issues.
Plain-English summary
Biomet 3i, LLC is recalling certain Gingihue 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, as well as numerous foreign countries.
The reason for the recall is that pouches containing the implants may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the devices.
Healthcare providers and patients should contact Biomet 3i for further instructions regarding the return or replacement of these specific dental implants.
The recalled product
- Product
- Certain 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 (12)
- Items: IMAP352G
- IMAP354G
- IAPP462G
- IAPP464G
- IAPP472G
- IAPP474G
- IWPP564G
- IWPP572G
- IWPP574G
- IWPP662G
- IWPP664G
- IWPP672G AND IWPP674G.
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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