Nobel Biocare Tapered Drills Recalled Due to Sterility Concerns
Nobel Biocare is recalling specific tapered dental drills because a packaging defect may compromise their sterility during shelf life.
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 a packaging defect, which is a low-risk contamination issue without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Nobel Biocare USA LLC is recalling specific Drill Tapered NP 3.5x10 mm Single-Pat devices. These guided tapered drills are used by medical professionals to prepare osteotomies for specific related implants.
The recall is due to a problem in the packaging sealing process at the supplier of the affected devices. Because of this issue, it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life.
The affected products were distributed worldwide, including in the United States and numerous international locations. The source text does not specify the number of units affected or report any illnesses or injuries. Consumers and healthcare providers should stop using these specific devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Drill Tapered NP 3.5x10 mm Single-Pat - Product Usage: The Guided Drills (Twist (Step) Drills, Guided Tapered Drills) are used for preparing osteotomies for the specific related implants.
- Manufacturer
- Nobel Biocare Usa 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)
- (01)07332747065688(10)73415 (01)07332747065688(10)73537 Catalog# 37075
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 · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12