Z-1496-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2024
- Initiation Date
- May 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 764 units
Product Description
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
Reason for Recall
Medical device components were marketed without FDA clearance and without FDA approval
Distribution Pattern
US Nationwide distribution in the state of WA.
Code Information
UDI/REF Number:00814193025807/01-01-0554, 00814193025814/01-01-0556, 00814193025821/01-01-0558, 00814193025838/01-01-0560, 00814193025845/01-01-0562, 00814193025852/01-01-0564, 00814193025869/01-01-0566, REF Number/Lot Number: 01-01-0562 01010562H1NN732, 01-01-0562 01010562HNN733, 01-01-0562 01010562J1NN745, 01-01-0564 01010564CNN656, 01-01-0564 01010564C3NN658, 01-01-0564 01010564CNN659, 01-01-0564 01010564DNN671, 01-01-0564 01010564D1NN681, 01-01-0564 01010564ENN697, 01-01-0564 01010564E2NN698, 01-01-0564 01010564FNN733, 01-01-0564 01010564G1NN744, 01-01-0564 01010564GNN746, 01-01-0566 01010566CNN663, 01-01-0566 01010566BNN670, 01-01-0566 01010566BNN671, 01-01-0566 01010566BNN688, 01-01-0566 01010566BNN689, 01-01-0566 01010566DNN699, 01-01-0566 01010556E1NN726, 01-01-0566 01010556E1NN727,