Nobel Biocare: Medical Device Recall in 2025 - (Recall #: Z-1101-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

. Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Nobel Biocare N1 TiUltra TCC implants are intended for use as an endosseous dental implant in the maxilla or mandible for anchoring or supporting dental protheses to restore chewing function

Product Classification:

Class II

Date Initiated: January 10, 2025

Date Posted: February 12, 2025

Recall Number: Z-1101-2025

Event ID: 96047

Reason for Recall:

Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching the sterile barrier of the finished product.

Status: Ongoing

Product Quantity: 1,558 units (90 units - U.S.)

Code Information:

Nobel Biocare N1 TiUltra TCC RP 4.0x 9mm Catalog Number: 300861 UDI-DI code: 07332747161731 Lot Numbers: 12253672 12253673 Nobel Biocare N1 TiUltra TCC RP 4.0x11mm Catalog Number: 300862 UDI-DI code: 07332747161748 Lot Numbers: 12253448 12254209 Nobel Biocare N1 TiUltra TCC RP 4.0x13mm Catalog Number: 300863 UDI-DI code: 07332747161755 Lot Numbers: 12253620 12254213

Distribution Pattern:

U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA.

Voluntary or Mandated:

Voluntary: Firm initiated