The Recall Desk
ModerateFDA (Devices)·Z-2422-2016·Announced 2016-08-24

Biomet 3i Recalls Dental Implants Due to Potential Unsealed Pouches

Biomet 3i, LLC is recalling 1,648,273 LDA Screw SBL 3mm(D) dental implants 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 potential packaging failure (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries.

Plain-English summary

Biomet 3i, LLC is recalling 1,648,273 units of LDA Screw SBL 3mm(D) dental implants (Item: SCRSBL1, Lot # 1087614). The recall is being conducted because pouches containing the implants may not have been sealed during the packing process.

The affected products 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 specific dates of distribution or installation.

Consumers and healthcare providers should stop using the affected dental implants and contact Biomet 3i, LLC for further instructions on how to return or replace the product.

The recalled product

Product
LDA Screw SBL 3mm(D) Item: SCRSBL1 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)

  • Lot # 1087614

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

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Same hazard · packaging defect

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