Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 150 dental implant abutments because a limited number of product 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, and the hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or labeling/packaging issue without reported injuries, fitting the Moderate criteria.
Plain-English summary
Biomet 3i, LLC is recalling 150 units of the BIOMET 3i CERTAIN LOW PROFILE 17° ABUTMENT 4.1MM(D) X 4MM(H). This product is a premanufactured prosthetic component used in dental implant rehabilitation. The recall is limited to specific lots: 2016011141, 2016020088, and 2016031214, with Part # ILPAC4417.
The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected products 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 and patient records for these specific lot numbers. If the product is found, it should be removed from use and returned to Biomet 3i, LLC according to their instructions.
The recalled product
- Product
- BIOMET 3i CERTAIN LOW PROFILE 17¿ ABUTMENT 4.1MM(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
- Hazard
- Affected units
- 150
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 (3)
- Part # ILPAC4417 Lot # 2016011141
- 2016020088
- and 2016031214
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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