Biomet 3i Recalls Flat Implant Cover Screws Due to Sealing Defects
Biomet 3i is recalling 1,648,273 Flat 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 specific defect is a packaging sealing issue 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 Flat Implant Cover Screw dental implants. The recall involves items with codes ICSF41, ICSF50, and ICSF60. The agency has classified this as a Class II recall.
The recall was initiated because pouches containing the devices may not have been sealed during packing. This defect could potentially affect the sterility or integrity of the packaging.
The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. Consumers and healthcare providers should contact Biomet 3i for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Certain Flat Implant 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 (2)
- Items: ICSF41
- ICSF50 and ICSF60
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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