Biomet 3i Recalls Dental Implant Cover Screws Due to Sealing Issues
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, but the hazard is a packaging defect (unsealed pouches) with no 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 the Implant Cover Screw (Item MMCS1) for dental implants. The recall is due to a manufacturing defect where the product pouches may not have been sealed during the packing process.
The affected devices were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. The source text does not specify specific lot numbers or expiration dates for the affected units.
Consumers and healthcare providers should stop using these specific cover screws and contact Biomet 3i, LLC for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- 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 (1)
- Item: MMCS1
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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