Nobel Biocare Recalls Implant Retrieval Kits Due to Sterility Concerns
Nobel Biocare is recalling 87 units of Implant Retrieval Kits because a packaging sealing issue may compromise the sterility of the devices during their 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 2/5 (Moderate).
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, and the hazard is a potential loss of sterility without reported illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 87 units of Implant Retrieval Kits. 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 remain sterile during their shelf-life.
The affected products are distributed worldwide, including in the United States and numerous international locations. The recall covers specific lot numbers and catalog number 37470, with manufacturing dates ranging from August 2018 to January 2019.
Consumers and healthcare providers should stop using the affected kits and contact Nobel Biocare USA LLC for instructions on how to return or dispose of the products.
The recalled product
- Product
- Implant 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
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 87
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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