Nobel Biocare Guided Tapered Drills Recalled for Sterility Concerns
Nobel Biocare is recalling 346 Guided Tapered Drills because a packaging sealing issue 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 for theoretical hazards without confirmed illness.
Plain-English summary
Nobel Biocare USA LLC is recalling 346 units of Drill Tapered RP 4.3x10 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 packaging issue, it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life. The affected units were distributed worldwide, including in the United States and numerous international locations such as Canada, Australia, Japan, Brazil, and various European countries.
Healthcare providers and consumers should stop using the affected devices and contact the recalling firm for further instructions or replacement.
The recalled product
- Product
- Drill Tapered RP 4.3x10 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
- 346
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)07332747065633(10)73433 (01)07332747065633(10)73495 Catalog# 37080
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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