The Recall Desk
LowFDA (Devices)·Z-0831-2017·Announced 2016-12-28

Biomet 3i Low Profile Dental Abutments Recalled for Packaging Seal Defects

Biomet 3i is recalling 735 low profile dental 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 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 735 units of the BIOMET 3i CERTAIN LOW PROFILE 17° ABUTMENT 4.1MM(D) X 2MM(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 # ILPAC4217 and include the following lot numbers: 2015112156, 2015112157, 2015112158, 2015112159, 2015120466, 2016010159, 2016031210, 2016040438, and 2016061525. These products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden.

The source text does not specify specific consumer actions or report any illnesses or injuries associated with this recall.

The recalled product

Product
BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(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 Abutment
Hazard
Affected units
735

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 # ILPAC4217 Lot # 2015112156
  • 2015112157
  • 2015112158
  • 2015112159
  • 2015120466
  • 2016010159
  • 2016031210
  • 2016040438
  • and 2016061525

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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