Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 2,470 implant retrieval instruments because a packaging defect may compromise sterility. The devices are distributed worldwide.
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 potential loss of sterility due to packaging defects, which is a low-risk contamination issue without reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 2,470 units of the Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm. These medical devices are used to remove dental implants if the implant connection has been damaged, specifically for internal conical, internal tri-channel, or external hex connections.
The recall is due to a problem in the packaging sealing process at the supplier of the affected devices. Because of this defect, it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life. The affected products have been distributed worldwide, including in the United States and numerous other countries.
Healthcare professionals and consumers should stop using these devices and contact Nobel Biocare USA LLC for instructions on return or replacement. The recall number is Z-1316-2020.
The recalled product
- Product
- Implant Retrieval Instrument Hex & Tri-Ch NP/RP 22mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 2,470
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Nobel Biocare Usa 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 24 products in this recall →Related recalls
Same manufacturer · Nobel Biocare Usa Llc
See all →- HighNobelReplace dental implant components recalled for driver engagement defect
FDA (Devices) · 2022-03-02
- SevereNobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2020-05-13
- ModerateNobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13
Same hazard · loss of sterility
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighDaig Livewire Steerable Reprocessed Electrophysiology Catheter Recall
FDA (Devices) · 2026-05-20
- HighMedihoney Calcium Alginate Dressings Recalled Due to Potential Sterile Barrier Breach
FDA (Devices) · 2026-02-25
- SevereChloraPrep One-Step Applicators Recalled Due to Compromised Sterile Packaging
FDA (Drugs) · 2025-05-28
- HighProxima Drape sterile drapes recalled for potential packaging breach risk
FDA (Devices) · 2025-03-26