Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 27 specific 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 source text identifies the issue as a packaging-only problem (unsealed pouches) without reporting any injuries, illnesses, or functional defects in the medical device itself.
Plain-English summary
Biomet 3i, LLC is recalling 27 units of the BIOMET 3i CERTAIN LOW PROFILE 30° ABUTMENT 3.4MM(D) X 5MM(H). This product is a premanufactured prosthetic component used in dental implant rehabilitation. The recall is limited to Part # ILPAC3530, Lot # 2016030311.
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 units 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 or records for this specific part and lot number. If the product is identified, 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 30¿ ABUTMENT 3.4MM(D) X 5MM(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
- 27
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 # ILPAC3530 Lot # 2016030311
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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