Synovo Production FDA Recalls

3 recalls on file across devices, 0 of them Class I and 3 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0Class IIMay 30, 2023Medical device components were marketed without FDA clearan	Medical device components were marketed without FDA clearance and without FDA approval	Class IIDevices	May 30, 2023
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 0Class IIMay 30, 2023Medical device components were marketed without FDA clearan	Medical device components were marketed without FDA clearance	Class IIDevices	May 30, 2023
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01Class IIMay 30, 2023Medical device components were marketed without FDA clearan	Medical device components were marketed without FDA clearance	Class IIDevices	May 30, 2023