Biomet 3i Recalls Dental Implant Temporary Screws Due to Sealing Defect
Biomet 3i, LLC is recalling Standard Abutment Temporary 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 Standard Abutment Temporary Screws (Item: TS250) used in dental implants. The recall was initiated because pouches containing the devices may not have been sealed during the packing process.
The recall covers 1,648,273 devices distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as numerous foreign countries. The agency has classified this as a Class II recall.
Consumers and healthcare providers should contact Biomet 3i, LLC for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Standard Abutment Temporary 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: TS250
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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