Nobel Biocare Recalls Abutment Screw Retrieval Kits Due to Sterility Concerns
Nobel Biocare is recalling 7 units of Abutment Screw Retrieval Kits because a packaging sealing issue may compromise the sterility of the included medical devices.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a potential loss of sterility due to a packaging defect but does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 7 units of the Abutment Screw Retrieval Kit (Catalog # 37481). The recall is 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 included in the kits remain sterile during their shelf-life.
The affected products were distributed worldwide, including in the United States and numerous international locations such as Canada, Australia, Japan, Brazil, South Africa, Russia, and various European countries. The specific lot numbers associated with this recall are 818727 and 818683.
Healthcare professionals and consumers who possess these specific kits should stop using them and contact Nobel Biocare for instructions on how to return or dispose of the products. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Abutment Screw Retrieval Kit - Product Usage: The kit itself does not have a specific intended Use, but included devices have specific intended use as shown above.
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 7
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)07332747083866(10)818727 (01)07332747083866(10)818683 Catalog# 37481
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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