Nobel Biocare: . 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 us

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.

Details from the source

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. Distribution: U.S. Nationwide distribution in the states of CA, FL, IL, MA, NJ, NY, OH, PA, UT, VA and WA. Quantity: 1,558 units (90 units - U.S.) Lot/code info: 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

UPC codes

07332747161731, 07332747161748, 07332747161755

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.