Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defect
Biomet 3i is recalling 1,648,273 dental implant cover screws 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) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Certain Implant Straight Cover Screw dental implants. The recall was initiated because the product pouches may not have been sealed during the packing process.
The affected devices are identified by item code ICS400. These products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
Consumers and healthcare providers should stop using these devices and contact Biomet 3i, LLC for further instructions on how to return or replace the affected products.
The recalled product
- Product
- Certain Implant Straight Cover Screw 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 (1)
- Item: ICS400
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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