Biomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
Biomet 3i is recalling specific low-profile 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 defect is limited to packaging seals, which is a packaging-only problem with no reported injuries or illnesses.
Plain-English summary
Biomet 3i, LLC is recalling 431 units of the BIOMET 3i CERTAIN LOW PROFILE 30° ABUTMENT 4.1MM(D) X 3MM(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 Part # ILPAC4330 with Lot # 2015111372, 201611713, 2016020101, and 2016050131.
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.
Dental professionals and patients who have used or possess these specific abutments should contact Biomet 3i, LLC for further instructions regarding the recall.
The recalled product
- Product
- BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 4.1MM(D) X 3MM(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
- 431
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 # ILPAC4330 Lot # 2015111372
- 201611713
- 2016020101
- and 2016050131
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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