Recall Z-1319-2020— Nobel Biocare Usa Llc
Class II · Terminated
Class II FDA medical device recall by Nobel Biocare Usa Llc, initiated 2019-03-14, terminated 2024-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Implant Retrieval Instrument CC NP & Ext 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 connection.. Reason: Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life..
- Recalling firm
- Nobel Biocare Usa Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-14
- Terminated
- 2024-02-15
- Firm location
- Yorba Linda, CA, United States
Product description
Implant Retrieval Instrument CC NP & Ext 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 connection.
Reason for recall
Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.