Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Medical device components were marketed without FDA clearance and without FDA approval
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / 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,
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Nationwide distribution in the state of WA.
Recall record
- Recalling firm
- Synovo Production
- Product type
- Devices
- Recall number
- Z-1496-2024
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Fullerton, CA
- Recall initiated
- 2023-05-30
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-1496-2024 · Source: openFDA enforcement.