Nobel Biocare Dental Drills Recalled Due to Packaging Seal Defects
Nobel Biocare is recalling 264 tapered dental drills because a packaging sealing 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 (sterile medical device) where the hazard is theoretical (potential loss of sterility) and no injuries or illnesses have been reported, fitting the High severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 264 units of Drill Tapered WP 5x10 mm Single-Pat dental drills. These devices are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
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.
The affected products were distributed worldwide, including in the United States and numerous international markets. Consumers and healthcare providers should stop using these specific drills and contact the manufacturer for further instructions.
The recalled product
- Product
- Drill Tapered WP 5x10 mm Single-Pat - Product Usage: Drills are intended to be used in the upper and lower jaw bone to prepare osteotomy prior to implant placement.
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 264
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)07332747065589(10)73287 (01)07332747065589(10)73428 Catalog# 37085
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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