The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2466-2016·Announced 2016-08-24

Biomet 3i Recalls Gold Slotted Screw Dental Implants for Sealing Defects

Biomet 3i is recalling Gold Slotted Screw Dental implants 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, which typically indicates a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue, fitting the Moderate criteria for voluntary precautionary recalls or minor defects.

Plain-English summary

Biomet 3i, LLC is recalling Gold Slotted Screw Dental implants (items GS200 and GS300) because the pouches containing the devices may not have been sealed during the packing process. The recall involves 1,648,273 devices.

The affected products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. The source text does not specify a date range for the distribution or the specific number of units distributed to each location.

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 information or a return address.

The recalled product

Product
Gold Slotted 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)

  • Items: GS200 and GS300.

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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.

See all 119 products in this recall →

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