The Recall Desk
LowFDA (Devices)·Z-2434-2016·Announced 2016-08-24

Biomet 3i Recalls Pick-Up Impression Coping Dental Implants

Biomet 3i is recalling Pick-Up Impression Coping dental implants because pouches may not have been sealed during packing.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a packaging defect (unsealed pouches) without reporting any illnesses, injuries, or deaths. Per the rubric, packaging-only problems or documentation issues without reported harm are typically scored as Low (1) or Moderate (2). Given the lack of reported adverse events and the specific nature of the defect, a score of 1 is appropriate.

Plain-English summary

Biomet 3i, LLC is recalling Pick-Up Impression Coping dental implants (Item: MIC33). The recall involves 1,648,273 units that were distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.

The recall was initiated because the pouches containing the implants may not have been sealed during the packing process. This packaging defect could potentially compromise the sterility or integrity of the medical devices.

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

The recalled product

Product
Pick-Up Impression Coping 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: MIC33

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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