The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-0839-2017·Announced 2016-12-28

Biomet 3i Low Profile One-Piece Abutment Recall for Packaging Seal Defects

Biomet 3i is recalling 450 units of Low Profile One-Piece Abutments 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 for a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, which aligns with the rubric criteria for a Low severity score.

Plain-English summary

Biomet 3i, LLC is recalling 450 units of the BIOMET 3i Certain Low Profile One-Piece Abutment 4.1mm(D) x 1mm(H). This endosseous dental implant abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.

The recall is due to a packaging defect where a limited number of product pouches may not have been sealed during the packaging process. The affected products are identified by Part # ILPC441U and Lot # 2015112073, 2016040049, 2016040914, and 2016042048.

The affected units 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 next steps for these specific units.

The recalled product

Product
BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 1MM(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
450

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 # ILPC441U Lot # 2015112073
  • 2016040049
  • 2016040914
  • and 2016042048

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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