Nobel Biocare: Medical Device Recall in 2022 - (Recall #: Z-1565-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Nobel Biocare N1 TiUltra TCC NP 3.5x13mm

Product Classification:

Class II

Date Initiated: July 25, 2022

Date Posted: August 31, 2022

Recall Number: Z-1565-2022

Event ID: 90679

Reason for Recall:

Due to the presence of a burr which may cause an aspiration risk to patient during surgical procedure.

Status: Ongoing

Product Quantity: 347 devices

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

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

Voluntary or Mandated:

Voluntary: Firm initiated