Agency classClass IIOur severity:Low FDA (Devices)·Z-0855-2017·Announced 2016-12-28

Biomet 3i Low Profile Abutment Healing Caps Recalled for Packaging Defects

Biomet 3i is recalling 391 Low Profile Abutment Healing Caps because a limited number of 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 1/5 (Low).

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

Our severity reasoning: The recall is classified as Low severity because the issue is a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or documentation issues.

Plain-English summary

Biomet 3i, LLC is recalling 391 units of the BIOMET 3i Low Profile Abutment Healing Cap. This product is an endosseous dental implant abutment, a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. The recall involves specific lots: 2016030791, 2016030792, 2016030793, and 2016060693.

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

The source text does not specify instructions for consumers or healthcare providers regarding the disposal or return of these specific units. Users should verify their product lot numbers against the list provided in the official recall notice.

The recalled product

Product: BIOMET 3i LOW PROFILE ABUTMENT HEALING CAP 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
Hazard: packaging-defect
Affected units: 391

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 (4)

Part # LPCHC Lot # 2016030791
2016030792
2016030793
and 2016060693

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