Nobel Biocare Recalls Tapered Dental Drills Due to Sterility Concerns
Nobel Biocare is recalling 260 units of tapered dental drills because a packaging sealing issue may compromise sterility during 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: This is an FDA Class II recall involving a potential loss of sterility. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Nobel Biocare USA LLC is recalling 260 units of Drill Tapered RP 4.3x11.5 mm Single-Pat. These guided tapered drills 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 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 other countries. 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 RP 4.3x11.5 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
- Affected units
- 260
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)07332747065626(10)73474 (01)07332747065626(10)73369 Catalog# 37081
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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