Recall Z-1322-2020— 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: 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 screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.. 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
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 screw, a screw tap repair can be used. The instruments are intended for both simple and advanced treatments.
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.