Synovo Production

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1496-2024Class IIACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, RefereMay 30, 2023
Z-1497-2024Class IIACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-0May 30, 2023
Z-1498-2024Class IIFemoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference NMay 30, 2023