Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 11 units of Implant Retrieval Instrument Tri Channel 6.0 22 mm because a packaging sealing issue may compromise sterility.
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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 11 units of the Implant Retrieval Instrument Tri Channel 6.0 22 mm. These instruments are used to remove dental implants with internal conical, internal tri-channel, or external hex connections if the implant connection is damaged.
The recall was initiated because a problem in the packaging sealing process at the supplier means it cannot be guaranteed that the sterilized medical devices remain sterile during their shelf-life. The affected units were distributed worldwide, including in the United States and numerous international locations.
Consumers and healthcare providers should stop using the affected instruments and contact Nobel Biocare USA LLC for further instructions on how to proceed.
The recalled product
- Product
- Implant Retrieval Instrument Tri Channel 6.0 22 mm - Product Usage: They can be used to remove implants, if the implant connection has been damaged. It can be used to remove implants with internal conical connection, internal tri-channel connection or external hex connection.
- Manufacturer
- Nobel Biocare Usa Llc
- Hazard
- Affected units
- 11
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)07332747083811(10)73313 Catalog# 37476
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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