The Recall Desk

Manufacturer

Synovo Production

3 recalls in our database name Synovo Production as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2024-04-17

Of the 3 recalls from Synovo Production we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • HighFDA (Devices)·Z-1496-2024·2024-04-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1498-2024·2024-04-17

    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
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1497-2024·2024-04-17

    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
    Medical Device
    Distribution
    Distributed nationwide