The Recall Desk

FDA (Devices) recall action 94278

Synovo Production recalled 3 products on 2024-04-17

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2024-04-17
Critical
0
Units
2,941

Why these products were recalled

Medical device components were marketed without FDA clearance and without FDA approval

Medical device components were marketed without FDA clearance

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2024-04-17

    Acetabular Fixation Cups Recalled for Marketing Without FDA Clearance

    Synovo Production is recalling 764 acetabular fixation cups marketed without FDA clearance or approval. These hip replacement components were distributed nationwide in Washington state.

    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2024-04-17

    Femoral Resurfacing Cup Components Marketed Without Required FDA Clearance

    Synovo Production recalled 496 femoral resurfacing cup components that were marketed without FDA clearance. These hip implant components were distributed in the United States.

    Product
    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
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2024-04-17

    Acetabular Bearing Components Recalled for Marketing Without FDA Clearance

    Synovo Production is recalling 1,681 acetabular bearing components that were marketed without FDA clearance.

    Product
    ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
    Category
    Distribution
    1 state