The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0845-2017·Announced 2016-12-28

Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

Biomet 3i is recalling a limited number of Low Profile 30-degree abutments because some product 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a packaging seal defect, which is a quality control issue rather than a direct structural failure or high-risk pathogen, fitting the Moderate severity criteria for low-risk contamination or voluntary precautionary measures.

Plain-English summary

Biomet 3i, LLC is recalling a limited number of BIOMET 3i LOW PROFILE 30° ABUTMENT 3.4MM(D) X 5MM(H) units. These endosseous dental implant abutments are premanufactured prosthetic components intended for use as an aid in prosthetic rehabilitation. The recall involves 4 units with Part # LPAC3530 and Lot # 2015110514.

The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. This defect could potentially compromise the sterility or integrity of the device, though the source text does not specify reported injuries or illnesses.

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 who have received these specific abutments should contact Biomet 3i, LLC for further instructions on how to proceed.

The recalled product

Product
BIOMET 3i LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) 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
Affected units
4

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)

  • Part # LPAC3530 Lot # 2015110514

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 →

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