Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 246 dental implant abutments because a limited number of 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 issue is a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or packaging defects.
Plain-English summary
Biomet 3i, LLC is recalling 246 units of the BIOMET 3i LOW PROFILE 17° ABUTMENT 4.1MM(D) X 2MM(H). This endosseous dental implant abutment is a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation. The recall is limited to specific lots: 2015110506, 2016030834, 2016042066, and 2016042068.
The recall was initiated because a limited number of product pouches may not have been sealed during the packaging process. The affected products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden.
Healthcare professionals and consumers should stop using the affected abutments and contact Biomet 3i, LLC for further instructions on the recall.
The recalled product
- Product
- BIOMET 3i LOW PROFILE 17¿ 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
- 246
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 (4)
- Part # LPAC4217 Lot # 2015110506
- 2016030834
- 2016042066
- 2016042068
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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