The Recall Desk
ModerateFDA (Devices)·Z-2488-2016·Announced 2016-08-24

Biomet 3i Recalls Micromini Flat Implant Cover Screws for Sealing Defects

Biomet 3i is recalling Micromini 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, and the hazard is 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 certain Micromini Flat Implant Cover Screws (Item: IMCSF34) used in dental implants. The recall involves 1,648,273 devices that were distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The reason for the recall is that the 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.

Healthcare professionals and consumers should stop using these specific cover screws and contact Biomet 3i, LLC for further instructions on how to return or replace the affected products.

The recalled product

Product
Certain Micromini 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 (1)

  • Item: IMCSF34

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · packaging defect

See all →