Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling 124 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, fitting the 'Low' severity criteria for cosmetic or packaging defects.
Plain-English summary
Biomet 3i, LLC is recalling 124 units of the BIOMET 3i LOW PROFILE ONE-PIECE ABUTMENT 4.1MM(D) X 4MM(H). This product is a premanufactured prosthetic component used in dental implant rehabilitation. The recall is limited to Part # LPC444U, Lot # 2016030294.
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.
Healthcare professionals 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 Biomet 3i, LLC in accordance with their recall instructions.
The recalled product
- Product
- BIOMET 3i LOW PROFILE ONE-PIECE 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
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 124
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 # LPC444U Lot # 2016030294
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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