Nobel Biocare recalls . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP 4.0x11mm . Nobel Biocare N1 TiUltra TCC RP

Recalled February 12, 2025 · FDA recall Z-1101-2025 · Nobel Biocare

Hazard

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. · FDA Class II

Units

1,558 units (90 units - U.S.)

Sold at

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

Description

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.

Product

. 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

Manufacturer(s)

Nobel Biocare

Made in

Sweden

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →