Z-1565-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 31, 2022
- Initiation Date
- July 25, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 347 devices
Product Description
Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
Reason for Recall
Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Distribution Pattern
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
Code Information
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