Nobel Biocare Recalls Tapered Drills Due to Sterility Concerns
Nobel Biocare is recalling 473 tapered dental drills because a packaging defect may compromise sterility during shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 473 units of Drill Tapered NP 3.5x11.5 mm Single-Pat devices. These guided tapered drills are used by dental professionals to prepare osteotomies for specific related implants. The recall covers units distributed worldwide, including the United States and numerous international markets.
The recall was initiated due to a problem in the packaging sealing process at the supplier of the affected devices. As a result, it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life. This potential loss of sterility poses a risk of infection if the devices are used in surgical procedures.
Healthcare providers and distributors should stop using the affected devices immediately. Users should check their inventory for the specific product and catalog number 37076. Affected units should be quarantined and returned to the manufacturer or their authorized representative for further instructions.
The recalled product
- Product
- Drill Tapered NP 3.5x11.5 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
- 473
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)07332747065671(10)73280 Catalog# 37076
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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