Biomet 3i Recalls Headless Dental Implant Cover Screws Due to Sealing Defect
Biomet 3i is recalling headless 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. The hazard involves potential packaging failure (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries or illnesses, fitting the Moderate criteria for voluntary precautionary or minor defects.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 headless dental implant cover screws (Item CS275). The recall was initiated because pouches containing these devices 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 the exact dates of distribution or the specific dental practices or patients affected.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions on how to handle the recalled devices. The source text does not provide specific contact details or a return address.
The recalled product
- Product
- Cover Screw, Headless Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- 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: CS275
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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