The Recall Desk
LowFDA (Devices)·Z-0861-2017·Announced 2016-12-28

Biomet 3i Low Profile Abutment Recall for Unsealed Packaging

Biomet 3i is recalling 1,371 low profile abutments because a limited number of 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 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 1,371 units of the BIOMET 3i Low Profile Abutment Non-Hexed Temporary Cylinder. This endosseous dental implant abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.

The recall is being conducted because a limited number of product pouches may not have been sealed during packaging. The affected products are identified by Part # LPCTC2 and specific lot numbers listed in the agency record.

The products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden. Healthcare professionals and patients should contact Biomet 3i, LLC for further instructions regarding the return or replacement of these specific units.

The recalled product

Product
BIOMET 3i LOW PROFILE ABUTMENT NON-HEXED TEMPORARY CYLINDER 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
1,371

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 (16)

  • Part # LPCTC2 Lot's # 2015111121
  • 2015120492
  • 2015120495
  • 2015120497
  • 2015121108
  • 2015121114
  • 2015121115
  • 2016011524
  • 2016031197
  • 2016031875
  • 2016031878
  • 2016050008
  • 2016060232
  • 2016060233
  • 2016060234
  • and 2016062347

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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