FDAFDA · Food and drugs·Recall number 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
Published April 17, 2024 · Recall initiated: May 30, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medical device components were marketed without FDA clearance
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Synovo Production
- Distributor
- US Nationwide distribution in the state of WA.
- Lot
- 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,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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