Nobel Biocare Recalls Screw Taps Due to Packaging Seal Defects
Nobel Biocare is recalling Screw Tap Tapered WP Single-Pat devices because a packaging sealing defect may compromise sterility during shelf life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 where sterility cannot be guaranteed, but the source text does not report any injuries or illnesses, fitting the High severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling Screw Tap Tapered WP Single-Pat devices, which are guided drills 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 defect, 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 international countries.
Healthcare providers and consumers should stop using the affected devices and contact Nobel Biocare USA LLC for further instructions on how to proceed.
The recalled product
- Product
- Screw Tap Tapered WP 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
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)07332747065701(10)73499 Catalog# 37052
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.
See all 24 products in this recall →Related recalls
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