The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0836-2017·Announced 2016-12-28

Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

Biomet 3i is recalling 101 units of a specific dental implant abutment 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 defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Biomet 3i, LLC is recalling 101 units of the BIOMET 3i Certain Low Profile One-Piece Abutment 3.4mm(D) x 2mm(H). This product is a premanufactured prosthetic component used in dental implant rehabilitation. The recall is limited to Part # ILPC342U, Lot # 2016020057.

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 medical device.

The affected units 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 part and lot numbers listed above. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to their instructions.

The recalled product

Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 2MM(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
Hazard
Affected units
101

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 # ILPC342U Lot # 2016020057

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 →

Related recalls

Same manufacturer · Biomet 3i, LLC

See all →

Same hazard · packaging defect

See all →

Similar recalls