Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 132 units of Abutment Screw Retrieval Instrument RP/WP/6.0 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, but the source text explicitly states no illnesses or injuries have been reported. The hazard is a theoretical risk of sterility compromise due to packaging defects, which aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Nobel Biocare USA LLC is recalling 132 units of the Abutment Screw Retrieval Instrument RP/WP/6.0 (Catalog # 37504). These instruments are used to retrieve broken abutment screws from dental implants and clean implant threads. The recall is due to a problem in the packaging sealing process at the supplier, which means it cannot be guaranteed that the sterilized devices remain sterile during their shelf life.
The affected devices were distributed worldwide, including in the United States and numerous international markets. The source text does not report any illnesses or injuries associated with this recall. Consumers and healthcare providers should stop using the affected instruments and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Abutment Screw Retrieval Instrument RP/WP/6.0 - Product Usage: The instruments for abutment screw retrieval can be used if an abutment screw is broken and a part of the screw is left inside the implant screw channel. If the implant thread needs to be cleaned before placing a new
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 132
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)07332747084092(10)73562 Catalog# 37504
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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