FDAFDA · Food and drugs·Recall number Z-1565-2022
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Published August 31, 2022 · Recall initiated: July 25, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nobel Biocare
- Distributor
- U.S Nationwide.: AZ, CA, CT, FL, HI, NC, NY, OR, PA, TX, UT, and WI O.U.S.: Austria, Belgium, Canada, Germany, Spain, France, United Kingdom, Hungary, Iceland, Italy, Netherlands, Norway, Portugal, and Sweden
- Lot
- Catalog number: 300859 Lot numbers / UDI Codes: 12167337 / (01)07332747161717(10)12167337(11)210119(17)251218 12167830 / (01)07332747161717(10)12167830(11)210125(17)251224 12168184 / (01)07332747161717(10)12168184(11)210128(17)251227
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Sweden
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