Reported Apr 17, 2024 · Ongoing
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558…
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 BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO
- Reference Numbers01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
- Lot codes and dates
7 of 7 products · 7 lot codes
Recalled lot codes, grouped by product number UDI REF Number 0081419302590601-02-4254
0081419302591301-02-4456
0081419302592001-02-4558
0081419302593701-02-4760
0081419302596801-02-4962
0081419302594401-02-5164
0081419302595101-02-5266
- Amount recalled
- 1681 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.
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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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