The Recall Desk
Agency classClass IIOur severity:LowFDA (Devices)·Z-0862-2017·Announced 2016-12-28

Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects

Biomet 3i is recalling 191 Low Profile Abutment units because some 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, fitting the 'Low' severity criteria for cosmetic or packaging defects.

Plain-English summary

Biomet 3i, LLC is recalling 191 units of the BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING. This product is an endosseous dental implant abutment intended for use as an aid in prosthetic rehabilitation. The recall is limited to specific lots: 2015110366, 2015110389, 2015110450, 2015110451, 2015110452, 2016021488, 2016021489, 2016021490, and 2016040888, under Part # LPCTIC2.

The reason for the recall is that a limited number of product pouches may not have been sealed during the packaging process. 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 or records for the specific lot numbers listed above. If the product is found, it should be removed from use and returned to Biomet 3i, LLC in accordance with their recall instructions.

The recalled product

Product
BIOMET 3i LOW PROFILE ABUTMENT (NON-HEXED) TRANSFER IMPRESSION COPING 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
191

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 (9)

  • Part # LPCTIC2 Lots # 2015110366
  • 2015110389
  • 2015110450
  • 2015110451
  • 2015110452
  • 2016021488
  • 2016021489
  • 2016021490
  • and 2016040888

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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