The Recall Desk
LowFDA (Devices)·Z-0856-2017·Announced 2016-12-28

Biomet 3i Dental Implant Abutment Recall for Packaging Seal Defects

Biomet 3i is recalling 28 dental implant abutments because some product pouches may not have been sealed during packaging.

What this means for you

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 because it involves 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 28 units of the BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP IMPRESSION COPING. This product is an endosseous dental implant abutment intended for use as an aid in prosthetic rehabilitation. The recall is limited to Part # LPCPIC1, Lot # 2015110454.

The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. 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 Biomet 3i, LLC in accordance with the recall instructions.

The recalled product

Product
BIOMET 3i LOW PROFILE ABUTMENT (HEXED) PICK-UP 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
28

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 # LPCPIC1 Lot # 2015110454

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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