Biomet 3i Recalls IOL Distal Extension Dental Implants Due to Sealing Defects
Biomet 3i, LLC is recalling IOL Distal Extension dental implants because pouches may not have been sealed during packing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging defect (unsealed pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling IOL Distal Extension dental implants. The recall involves 1,648,273 devices that were distributed worldwide, including the United States, Hawaii, Guam, Puerto Rico, the Virgin Islands, and numerous foreign countries.
The recall was initiated because the pouches containing the implants may not have been sealed during the packing process. This defect could potentially compromise the sterility or integrity of the devices.
Healthcare professionals and consumers who have these specific dental implants should contact Biomet 3i, LLC for further instructions on how to proceed with the recall.
The recalled product
- Product
- IOL Distal Extension Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
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)
- Item: IOLDE
Distribution
Part of a larger recall action
This product is one of 119 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.
See all 119 products in this recall →Related recalls
Same manufacturer · Biomet 3i, LLC
See all →- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- HighBiomet 3i Recalls Misaligned BellaTek Encode Definitive Abutments
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls BellaTek Titanium Abutments Due to Manufacturing Misalignment
FDA (Devices) · 2020-10-14
- ModerateBiomet 3i Recalls Misaligned BellaTek Dental Abutments
FDA (Devices) · 2020-10-14
Same hazard · packaging defect
See all →- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- ModerateAmneal Recalls Estradiol Gel Packets Due to Empty or Partially Full Containers
FDA (Drugs) · 2026-10-07
- HighCardinal Health Recalls Presource Convenience Kits Due to Seal Defects
FDA (Devices) · 2026-09-30
- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighCardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
FDA (Devices) · 2026-09-30
Similar recalls
- LowBiomet 3i Recalls 92 Dental Implants Due to Packaging Error
FDA (Devices) · 2016-09-28
- LowBiomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- ModerateBiomet 3i Dental Implant Recall Due to Outer Box Mislabeling
FDA (Devices) · 2013-08-21
- LowBiomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Low Profile Dental Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Dental Implant Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28