Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Defects
Biomet 3i, LLC 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 voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of certain Implant Cover Screw Dental implants. The affected items include codes ICS375, ICS500, and ICS600. The recall was initiated because the pouches containing these devices may not have been sealed during the packing process.
The recalled products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. The source text does not specify a particular date range for the distribution or the recall initiation.
Consumers and healthcare providers should stop using the affected dental implant cover screws and contact Biomet 3i, LLC for further instructions on how to return or replace the devices.
The recalled product
- Product
- Certain Implant Cover Screw Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Hazard
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 (2)
- Items: ICS375
- ICS500 and ICS600.
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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