Synovo Production: Medical Device Recall in 2024 - (Recall #: Z-1498-2024)

Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052

Class II

Medical device components were marketed without FDA clearance

UDI/REF Number: 00814193025708/01-03-0042; 00814193025678/01-03-0044; 00814193025692/01-03-0045; 00814193025685/01-03-0047; 00814193025654/01-03-0049; 00814193025661/01-03-0051; 00814193025753/01-03-0052; REF Number/Lot Number: 01-03-0044 01030044K2NN656, 01-03-0044 01030044K3NN736, 01-03-0045 01030045LNN657, 01-03-0045 01030045MNN670, 01-03-0045 01030045N1NN694, 01-03-0045 01030045NNN694, 01-03-0045 01030045QNN733, 01-03-0045 01030045RNN742, 01-03-0047 01030047LNN657, 01-03-0047 01030047L4NN662, 01-03-0047 01030047MNN674, 01-03-0047 01030047N1NN689, 01-03-0047 01030047NNN689, 01-03-0047 01030047QNN733, 01-03-0049 01030049MNN662, 01-03-0049 01030049M8NN670, 01-03-0049 01030049QNN687, 01-03-0049 01030049R1NN724, 01-03-0049 01030049RNN725, 01-03-0049 01030049UNN732, 01-03-0049 01030049UNN733, 01-03-0049 01030049NNN736, 01-03-0051 01030051K3NN658, 01-03-0051 01030051K4NN666, 01-03-0051 01030051K4NN667, 01-03-0051 01030051KNN673, 01-03-0051 01030051LNN685, 01-03-0051 01030051M1NN694, 01-03-0051 01030051M3NN694, 01-03-0051 01030051MNN694, 01-03-0051 01030051M4NN697, 01-03-0051 01030051NNN731, 01-03-0051 01030051N1NN732, 01-03-0051 01030051N1NN733, 01-03-0051 01030051Q1NN739, 01-03-0051 01030051QNN742, 01-03-0052 01030052JNN663, 01-03-0052 01030052KNN669, 01-03-0052 01030052GNN685, 01-03-0052 01030052LNN694, 01-03-0052 01030052L1NN694, 01-03-0052 01030052L2NN694, 01-03-0052 01030052L3NN694, 01-03-0052 01030052MNN733,

US Nationwide distribution in the state of WA.

Voluntary: Firm initiated