Biomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
Biomet 3i is recalling 50 units of Low Profile 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 it involves a packaging-only problem (unsealed pouches) with no reported injuries or illnesses, fitting the rubric criteria for cosmetic or packaging-only issues.
Plain-English summary
Biomet 3i, LLC is recalling 50 units of the BIOMET 3i Certain Low Profile Abutment 3.4mm(D) x 2mm(H). This product is an endosseous dental implant abutment, a premanufactured prosthetic component intended for use as an aid in prosthetic rehabilitation.
The recall is due to a packaging defect where a limited number of product pouches may not have been sealed during the packaging process. The affected units are identified by Part # ILPC342 and Lot # 2015121064 and 2016030816.
The affected products were distributed worldwide to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal, and Sweden. Consumers and healthcare providers should stop using the affected units and contact Biomet 3i, LLC for further instructions.
The recalled product
- Product
- BIOMET 3i CERTAIN LOW PROFILE ABUTMENT 3.4MM(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
- 50
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 # ILPC342 Lot # 2015121064 and 2016030816
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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