Product Safety Recalls

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Nobel Biocare Recall 90679

Description: Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Nobel Biocare Recall 90679 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1565-2022
Event ID90679
Event DescriptionNobel Biocare N1 TiUltra TCC NP 3.5x13mm
Product TypeDevices
DistributionU.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
Quantity347 devices
Recall ReasonDue to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.
Device Classification20220831
Device Code InfoCatalog 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
Center Classification Date20220823
Recall Initiation Date20220725
Recalling FirmNobel Biocare
Initial Notification Letter
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