The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0859-2017·Announced 2016-12-28

Biomet 3i Low Profile Abutment Quickbridge Recall for Unsealed Pouches

Biomet 3i is recalling 60 units of Low Profile Abutment Quickbridge 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, but 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 60 units of the BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE. This product is an endosseous dental implant abutment, a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. The specific units affected are identified by Part # LPCQB and Lot # 2016040022.

The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. The agency has classified this recall as Class II.

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 check their inventory for the specific lot number and stop using any unsealed units.

The recalled product

Product
BIOMET 3i LOW PROFILE ABUTMENT QUICKBRIDGE 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
60

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 # LPCQB Lot # 2016040022

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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