Biomet 3i Recalls Dental Implants Due to Unsealed Pouches
Biomet 3i is recalling specific dental implant copings 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, which typically indicates a situation where use may cause temporary or medically reversible health consequences. The hazard is a potential sterility issue due to unsealed packaging, which is a moderate risk without reported injuries.
Plain-English summary
Biomet 3i, LLC is recalling certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) dental implants (Item: IWIP50). The recall involves 1,648,273 units 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 affect the sterility of the devices.
Affected lots include 1157768-CN, 1160929-CN, 1160930-CN, 1160931-CN, 987129-5, 996343-5, and 998147-5. Healthcare providers and consumers should check their inventory for these specific lot numbers and contact Biomet 3i for instructions on how to proceed.
The recalled product
- Product
- Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 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 (7)
- Lot # 1157768-CN
- 1160929-CN
- 1160930-CN
- 1160931-CN
- 987129-5
- 996343-5
- and 998147-5
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 compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- LowBiomet 3i Dental Implant Abutment Recall for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- ModerateBiomet 3i Dental Implant Abutments Recalled for Packaging Seal Defects
FDA (Devices) · 2016-12-28
- 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
- ModerateBiomet 3i Low Profile Dental Implant Abutments Recalled for Packaging Defect
FDA (Devices) · 2016-12-28
- LowBiomet 3i Recalls 92 Dental Implants Due to Packaging Error
FDA (Devices) · 2016-09-28