Biomet 3i EP Healing Abutment Dental Implants Recalled for Unsealed Pouches
Biomet 3i is recalling EP Healing Abutment dental implants because pouches may not have been sealed during packing, potentially compromising sterility.
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 potential sterility issue due to unsealed packaging. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Biomet 3i, LLC is recalling EP Healing Abutment dental implants. The recall is due to a manufacturing issue where pouches may not have been sealed during packing. This defect could potentially affect the sterility of the devices.
The recall involves 1,648,273 devices. The products were distributed worldwide, including in the United States, Hawaii, Guam, Puerto Rico, and the Virgin Islands, as well as to numerous foreign consignees. Specific item codes affected include MHA32, MHA33, MHA34, MHA36, THA58, THA63, THA64, THA66, THA68, THA73, THA74, THA76, THA78, WTH52, WTH53, WTH54, WTH56, WTH58, WTH562, WTH563, WTH564, WTH566, WTH568, WTH572, WTH573, WTH574, WTH576, WTH578, WTH62, WTH63, WTH64, WTH66, WTH68, WTH672, WTH673, WTH674, WTH676, and WTH678.
Healthcare providers and consumers should stop using these devices and contact Biomet 3i, LLC for further instructions or a replacement.
The recalled product
- Product
- EP Healing Abutment Dental implants
- Manufacturer
- Biomet 3i, LLC
- Category
- Medical Device — Dental Implants
- Affected units
- 1,648,273
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 (20)
- Items: MHA32
- MHA33
- MHA34
- MHA36
- THA58
- THA63
- THA64
- THA66
- THA68
- THA73
- THA74
- THA76
- THA78
- WTH52
- WTH53
- WTH54
- WTH56
- WTH58
- WTH562
- WTH563
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 · sterility
See all →- SevereGood Sense Eye Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereCarolina Infusion Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Artificial Tears Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereApothecary NAD+ Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-10-14
Similar recalls
- ModerateBiomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Low Profile Abutment Healing Caps Recalled for Packaging Defects
FDA (Devices) · 2016-12-28
- ModerateBiomet 3i Dental Implant Abutments Recalled for Unsealed Packaging
FDA (Devices) · 2016-12-28
- LowBiomet 3i Dental Implant Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Low Profile Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- LowBiomet 3i Dental Abutments Recalled for Potential Packaging Seal Defects
FDA (Devices) · 2016-12-28