Biomet 3i Recalls Gold-Tite Hexed Retaining Screws Due to Sealing Issues
Biomet 3i is recalling Gold-Tite Hexed Retaining Screws because pouches may not have been sealed during packing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling Gold-Tite Hexed Retaining Screw Dental implants, specifically items GS200 and GS300. The recall involves 1,648,273 devices that were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The reason for the recall is that pouches containing the devices may not have been sealed during packing. This packaging defect could potentially compromise the sterility or integrity of the medical devices.
Consumers and healthcare providers should stop using these specific items and contact Biomet 3i, LLC for further instructions on how to return or replace the affected products.
The recalled product
- Product
- Gold -Tite Hexed Retaining Screw Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
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)
- Items: GS200 and GS300.
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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