Nobel Biocare Implant Retrieval Instruments Recalled for Sterility Concerns
Nobel Biocare is recalling 197 implant 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 involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 197 units of the Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm. These medical devices are used to remove dental implants if the implant connection has been damaged, specifically for internal conical, internal tri-channel, or external hex connections.
The recall was initiated 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 were distributed worldwide, including nationwide in the United States and in numerous international locations such as Canada, Australia, Japan, Brazil, South Africa, Russia, and various European countries. Consumers and healthcare providers should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Implant Retrieval Instrument Hex & Tri-Chi NP/RP 31mm - 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
- 197
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)07332747083774(10)73303 Catalog# 37472 & Tri-Chi
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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