Nobel Biocare Recalls Guided Start Drills Due to Sterility Concerns
Nobel Biocare is recalling Guided Start Drills because a packaging sealing issue may compromise the sterility of the devices during their 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, but the source text does not report any illnesses or injuries, and the hazard is a potential loss of sterility rather than a confirmed high-risk pathogen or structural defect.
Plain-English summary
Nobel Biocare USA LLC is recalling Guided Start Drills/Counterbore NobRpl NP, which are used for preparing 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 packaging 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 other countries.
Healthcare professionals and patients should stop using the affected devices and contact Nobel Biocare for further instructions on how to proceed.
The recalled product
- Product
- Guided Start Drills/Counterbore NobRpl NP - 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
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)07332747005295(10)73425 Catalog# 32737
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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