Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
Biomet 3i is recalling 53 units of Low Profile 17° Abutments because some pouches may not have been sealed during packaging.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a packaging defect (unsealed pouches) without reporting any illnesses, injuries, or hospitalizations. This aligns with the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Biomet 3i, LLC is recalling 53 units of BIOMET 3i Certain Low Profile 17° Abutment 3.4mm(D) x 4mm(H). These are endosseous dental implant abutments intended for use as an aid in prosthetic rehabilitation. The specific product is identified by Part # ILPAC3417 and Lot # 2015111355.
The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. This defect could potentially compromise the sterility or integrity of the medical device.
The affected units were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden. Healthcare providers 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 the manufacturer or distributor according to their instructions.
The recalled product
- Product
- BIOMET 3i CERTAIN LOW PROFILE 17¿ 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
- Affected units
- 53
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 # ILPAC3417 Lot # 2015111355
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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