Nobel Biocare Dental Drills Recalled Due to Sterility Concerns
Nobel Biocare is recalling specific 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, and the hazard is a theoretical risk of sterility loss due to packaging defects without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling specific tapered dental drills (Catalog # 37089) due to a problem in the packaging sealing process at the supplier. The issue affects the ability to guarantee that the sterilized medical devices remain sterile during their shelf life.
The affected products are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement. The recall covers devices distributed worldwide, including the United States and numerous international locations.
Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Drill Tapered 6.0 6x8 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
- Manufacturer
- Nobel Biocare Usa Llc
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)07332747065541(10)73575 Catalog# 37089
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.
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