Safety Alert Summary

Medical Device Safety Alert: "IVOCLAR VIVADENT AG IPS e.max ZirCAD CER/in. Prime BL1 C17/3 [Article Number: 758434; UDI-DI: (01)07615208438703, (11)231117, (10)Z063MW, (241)758434, (01)07615208438703, (11)231214, (10)Z067JD(241)758434; Lot Numbers: Z063MW, Z067JD] IPS e.max ZirCAD CER/in. Prime A1 C17/5 [Article Number: 758437; UDI-DI: (01)07615208438673, (11)231214, (10)Z067J5, (241)758437; (01)07615208438673, (11)231214, (10)Z067J6, (241)758437; (01)07615208438673, (11)240112, (10)Z06CBD, (241)758437; (01)07615208438673, (11)240112, (10)Z06CBF, (241)758437; Batch No. Z067J5, Z067J6, Z06CBD, Z06CBF], IPS e.max ZirCAD CER/in. Prime A2 C17/5 [Article Number: 758438; UDI-DI: (01)07615208438666, (11)231117, (10)Z063MX, (241)758438; (01)07615208438666, (11)231214, (10)Z067JH, (241)758438; (01)07615208438666, (11)240105, (10)Z06B6Y (241)758438; (01)07615208438666, (11)240118, (10)Z06D4N, (241)758438; Batch No. Z063MX, Z067JH, Z067J9, Z06B6Y, Z06D4N] IPS e.max ZirCAD CER/in. Prime A3 C17/5 [Article Number: 758439; UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214, (10)Z067JG, (241)758439; (01)07615208438659, (11)231214, (10)Z067JB, (241)758439; (01)07615208438659, (11)240105, (10)Z06B6Z (241)758439; (01)07615208438659, (11)240112, (10)Z06CBG, (241)758439; Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG], IPS e.max ZirCAD CER/in. Prime B1 C17/5 [Article Number: 758441; UDI-DI: (01)07615208438635, (11)231130, (10)Z065M0, (241)758441; (01)07615208438635, (11)240112, (10)Z06CBH, (241)758441; Batch No. Z065M0, Z06CBH], IPS e.max ZirCAD CER/in. Prime C2 C17/5 [Article Number: 758443; UDI-DI: (01)07615208438611, (11)231130, (10)Z065M1, (241)758443; Batch No.: Z065M1] "

02 May 2024