Reported Apr 17, 2024 · Ongoing
Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers: 01-03-0042…
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?
- Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO
- Reference Numbers01-03-0042 01-03-0044 01-03-0045 01-03-0047 01-03-0049 01-03-0051 01-03-0052
- Lot codes and dates
7 of 7 products · 7 lot codes
Recalled lot codes, grouped by product number UDI REF Number 0081419302570801-03-0042
0081419302567801-03-0044
0081419302569201-03-0045
0081419302568501-03-0047
0081419302565401-03-0049
0081419302566101-03-0051
0081419302575301-03-0052
- Amount recalled
- 496 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
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.
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