Femoral Resurfacing Cup - (xx)MM, Ti-6AI-4V ELI, TiN CERAMIC W/ PLASMA SPRAY, STERILEEO, Reference Numbers:…
Medical device recall Z-1498-2024. Published in FDA’s Enforcement Report on Apr 17, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 17, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 496 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Medical device components were marketed without FDA clearance
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
496 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI/REF Number: 00814193025708/01-03-0042; 00814193025678/01-03-0044; 00814193025692/01-03-0045; 00814193025685/01-03-0047; 00814193025654/01-03-0049; 00814193025661/01-03-0051; 00814193025753/01-03-0052; REF Number/Lot Number: 01-03-0044…
Every code shown here, 1,434 characters
UDI/REF Number: 00814193025708/01-03-0042; 00814193025678/01-03-0044; 00814193025692/01-03-0045; 00814193025685/01-03-0047; 00814193025654/01-03-0049; 00814193025661/01-03-0051; 00814193025753/01-03-0052; REF Number/Lot Number: 01-03-0044 01030044K2NN656, 01-03-0044 01030044K3NN736, 01-03-0045 01030045LNN657, 01-03-0045 01030045MNN670, 01-03-0045 01030045N1NN694, 01-03-0045 01030045NNN694, 01-03-0045 01030045QNN733, 01-03-0045 01030045RNN742, 01-03-0047 01030047LNN657, 01-03-0047 01030047L4NN662, 01-03-0047 01030047MNN674, 01-03-0047 01030047N1NN689, 01-03-0047 01030047NNN689, 01-03-0047 01030047QNN733, 01-03-0049 01030049MNN662, 01-03-0049 01030049M8NN670, 01-03-0049 01030049QNN687, 01-03-0049 01030049R1NN724, 01-03-0049 01030049RNN725, 01-03-0049 01030049UNN732, 01-03-0049 01030049UNN733, 01-03-0049 01030049NNN736, 01-03-0051 01030051K3NN658, 01-03-0051 01030051K4NN666, 01-03-0051 01030051K4NN667, 01-03-0051 01030051KNN673, 01-03-0051 01030051LNN685, 01-03-0051 01030051M1NN694, 01-03-0051 01030051M3NN694, 01-03-0051 01030051MNN694, 01-03-0051 01030051M4NN697, 01-03-0051 01030051NNN731, 01-03-0051 01030051N1NN732, 01-03-0051 01030051N1NN733, 01-03-0051 01030051Q1NN739, 01-03-0051 01030051QNN742, 01-03-0052 01030052JNN663, 01-03-0052 01030052KNN669, 01-03-0052 01030052GNN685, 01-03-0052 01030052LNN694, 01-03-0052 01030052L1NN694, 01-03-0052 01030052L2NN694, 01-03-0052 01030052L3NN694, 01-03-0052 01030052MNN733,
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US Nationwide distribution in the state of WA.
The states and territories these words name
- Washington
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 30, 2023.
- FDA classified it on Apr 8, 2024.
- FDA’s Enforcement Report published it on Apr 17, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Synovo Production, of Fullerton, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.