Biomet 3i Low Profile Dental Abutment Recall for Packaging Seal Defects
Biomet 3i is recalling 108 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 for a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, which aligns with the rubric criteria for a Low severity score.
Plain-English summary
Biomet 3i, LLC is recalling 108 units of the BIOMET 3i Certain Low Profile Abutment 4.1mm(D) x 2mm(H). This product is a premanufactured prosthetic component used in dental implant rehabilitation. The recall is limited to Part # ILPC442, Lot # 2016030811.
The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. The affected units 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 injuries or illnesses associated with this recall.
The recalled product
- Product
- BIOMET 3i CERTAIN LOW PROFILE 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
- Hazard
- Affected units
- 108
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 # ILPC442 Lot # 2016030811
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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