Nobel Biocare Abutment Screw Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 233 units of Abutment Screw Retrieval Instruments because a packaging defect may compromise sterility during shelf life.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of infection from non-sterile medical devices, which fits the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Nobel Biocare USA LLC is recalling 233 units of the Abutment Screw Retrieval Instrument 3.0/NP (Catalog # 37503). These instruments are used to remove 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 such as Canada, Australia, Japan, Brazil, and various European countries. The recall is classified as Class II by the FDA, indicating that use of the product could create a temporary or medically reversible health risk.
Healthcare providers and consumers should stop using the affected instruments and contact Nobel Biocare USA LLC for instructions on return or replacement. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Abutment Screw Retrieval Instrument 3.0/NP - 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 scr
- Manufacturer
- Nobel Biocare Usa Llc
- Affected units
- 233
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)07332747084085(10)73585 (01)07332747084085(10)73430 Catalog # 37503
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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