Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0858-2017·Announced 2016-12-28

Biomet 3i Dental Implant Abutments Recalled for Unsealed Packaging

Biomet 3i is recalling 270 low-profile dental implant abutments because some pouches may not have been sealed during packaging.

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, but the specific defect is a packaging seal issue with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling 270 units of the BIOMET 3i Low Profile Abutment Non-Hexed Preformed Temporary Cylinder. These are endosseous dental implant abutments intended for use as an aid in prosthetic rehabilitation. The recall affects specific lots (2016011174, 2016011175, and 2016011178) of Part #LPCPTC2.

The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. The affected products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden.

Healthcare professionals and patients should stop using the affected abutments and contact Biomet 3i for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product: BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED PREFORMANCE TEMPORARY CYLINDER An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Manufacturer: Biomet 3i, LLC
Category: Medical Device — Dental Implant Abutment
Hazard: packaging-defect
Affected units: 270

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 (2)

Part #LPCPTC2 Lot #'s 2016011174
2016011175 and 2016011178

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 36 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 36 products in this recall →

Same manufacturer · Biomet 3i, LLC

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Same hazard · packaging defect