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.
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. 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
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