Reported Apr 17, 2024 · Ongoing
ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO, Reference Numbers:…
Synovo Production
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synovo Production · 1501 N Harbor Blvd Ste 209 · Fullerton, CA · 92835-3803
Is this the product you have?
- ACETABULAR FIXATION CUP, (xx)MM, 5 HOLE, Ti-6AI-4V ELI TiN CERAMIC W/PLASMA SPRAY, STERILEEO
- Reference Numbers01-01-0554 01-01-0556 01-01-0558 01-01-0560 01-01-0562 01-01-0564 01-01-0566
- Lot codes and dates
- UDI/REF Number
00814193025807/01-01-055400814193025814/01-01-055600814193025821/01-01-055800814193025838/01-01-056000814193025845/01-01-056200814193025852/01-01-056400814193025869/01-01-0566
- REF Number/Lot Number
01-01-0562 01010562H1NN73201-01-0562 01010562HNN73301-01-0562 01010562J1NN74501-01-0564 01010564CNN65601-01-0564 01010564C3NN65801-01-0564 01010564CNN65901-01-0564 01010564DNN67101-01-0564 01010564D1NN68101-01-0564 01010564ENN69701-01-0564 01010564E2NN69801-01-0564 01010564FNN73301-01-0564 01010564G1NN74401-01-0564 01010564GNN74601-01-0566 01010566CNN66301-01-0566 01010566BNN67001-01-0566 01010566BNN67101-01-0566 01010566BNN68801-01-0566 01010566BNN68901-01-0566 01010566DNN69901-01-0566 01010556E1NN72601-01-0566 01010556E1NN727
- UDI/REF Number
- Amount recalled
- 764 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- WA
Why it was recalled
Medical device components were marketed without FDA clearance and without FDA approval
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Synovo Production recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.