Nobel Biocare Tapered Drills Recalled Due to Sterility Concerns
Nobel Biocare is recalling 154 units of Tapered RP 4.3x13 mm drills because a packaging defect may compromise sterility.
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 (sterile medical device) where the hazard is a potential loss of sterility, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Nobel Biocare USA LLC is recalling 154 units of Drill Tapered RP 4.3x13 mm Single-Pat. These guided tapered drills are used by medical professionals to prepare 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 products were distributed worldwide, including in the United States and numerous other countries. No specific lot numbers or dates are provided in the source text. Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Drill Tapered RP 4.3x13 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
- Hazard
- Affected units
- 154
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)07332747065619(10)73274 Catalog# 37082
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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