Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 64 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 severity because the hazard is limited to a packaging defect (unsealed pouches) with no reported injuries or illnesses, fitting the rubric criteria for packaging-only problems.
Plain-English summary
Biomet 3i, LLC is recalling 64 units of the BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(H). This product is a premanufactured prosthetic component used in dental implant rehabilitation. The recall is limited to Part # ILPC344U, specifically Lot # 2016011182 and 2016041553.
The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. This defect is a packaging issue rather than a defect in the implant abutment itself.
The affected products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden. Consumers and healthcare providers 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 the manufacturer or distributor for further instructions.
The recalled product
- Product
- BIOMET 3i CERTAIN LOW PROFILE ONE-PIECE ABUTMENT 3.4MM(D) X 4MM(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
- Hazard
- Affected units
- 64
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 # ILPC344U Lot # 2016011182 and 2016041553
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.
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