Nobel Biocare Dense Bone Drills Recalled for Sterility Concerns
Nobel Biocare is recalling 8 Dense Bone Drills because a packaging defect may compromise 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 source text describes a theoretical risk to sterility without reporting any specific illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 8 units of the Dense Bone Drill 6.0 6x16 mm Single-Patient Use device. The recall is due to a problem in the packaging sealing process at the supplier, which means it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf life.
The affected devices were distributed worldwide, including in the United States and numerous international locations. The specific catalog number for the recalled items is 37049.
Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Dense Bone Drill 6.0 6x16 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
- Hazard
- Affected units
- 8
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)07332747065756(10)73502 Catalog# 37049
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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