Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 526 Implant Retrieval Instruments because a packaging sealing issue may compromise sterility during shelf life.
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 hazard is a potential loss of sterility due to packaging defects, which is a low-risk contamination issue without reported illnesses or injuries, fitting the Moderate severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 526 units of the Implant Retrieval Instrument CC RP & Tri Ch Hex WP 22 mm (Catalog # 37475). 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 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 devices were distributed worldwide, including in the United States and numerous international locations. Users should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Implant Retrieval Instrument CC RP & Tri Ch Hex WP 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 connecti
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 526
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)07332747083804(10)73601 (01)07332747083804(10)73298 Catalog# 37475
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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