Recall archive / FDA device enforcement
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers: 01-0... — FDA record Z-1496-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 30, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- 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
- Medical device components were marketed without FDA clearance and without FDA approval
- Classification
- Class II
- Recalling firm
- Synovo Production
- Quantity
- 764 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1496-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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, |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of WA.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 17, 2024
- Recall initiation date
- May 30, 2023
- Center classification date
- Apr 8, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.