Biomet 3i Recalls Dental Implant Impression Copings Due to Sealing Issues
Biomet 3i, LLC is recalling 1,648,273 Provide Impression Coping dental implant devices because pouches may not have been sealed during packing.
What this means for you
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. The hazard is a packaging defect (unsealed pouches) which is a low-risk contamination or packaging issue, fitting the Moderate severity criteria for minor labeling/packaging errors or low-risk contamination.
Plain-English summary
Biomet 3i, LLC is recalling 1,648,273 units of Provide Impression Coping dental implant devices. The recall involves specific item codes: PIC484, PIC485, PIC654, PIC655, PIC484H, PIC485H, and PIC654H.
The reason for the recall is that the pouches containing the devices may not have been sealed during the packing process. This packaging defect could potentially compromise the sterility or integrity of the medical devices.
The affected products were distributed worldwide, including in the United States (nationwide, Hawaii, Guam, Puerto Rico, and the Virgin Islands) and numerous foreign countries. Consumers and healthcare providers should stop using these devices and contact Biomet 3i, LLC for further instructions on how to proceed.
The recalled product
- Product
- Provide Impression Coping 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 (6)
- Item:PIC484
- PIC485
- PIC654
- PIC655
- PIC484H
- PIC485H and PIC654H.
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 →- HighMD Wipe Outz Numbing Tattoo Wipes Recalled for Child Poisoning Risk
CPSC · 2026-08-27
- HighV-Loc 90 Absorbable Wound Closure Devices Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- SevereDermalon Sutures Recalled for Potential Sterile Barrier Packaging Defects
FDA (Devices) · 2026-08-19
- HighV-Loc 180 Absorbable Wound Closure Device Recalled for Packaging Defects
FDA (Devices) · 2026-08-19
- HighBiopsy Forceps Recall: Sterile Packaging Breach Risk
FDA (Devices) · 2026-08-12