Nobel Biocare Dental Drills Recalled Due to Sterility Concerns
Nobel Biocare is recalling 59 dental drills 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, but the source text does not report any illnesses or injuries. The hazard is a theoretical risk of compromised sterility due to a packaging defect, which aligns with the criteria for a moderate severity score involving low-risk contamination or precautionary measures without reported harm.
Plain-English summary
Nobel Biocare USA LLC is recalling 59 units of the Drill Tapered WP 5x11.5 mm Single-Pat. These dental instruments are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
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 devices were distributed worldwide, including in the United States and numerous international locations. Consumers and healthcare providers should stop using these devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Drill Tapered WP 5x11.5 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
- Affected units
- 59
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)07332747065572(10)73451 Catalog# 37086
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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