ACETABULAR BEARING (xx)MM I.D X (xx) O.D
Medical device recall Z-1497-2024. 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
- 1681 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?
ACETABULAR BEARING (xx)MM I.D X (xx) O.D. UHMWPE 1020, STERILEEO, Reference Numbers: 01-02-4254 01-02-4456 01-02-4558 01-02-4760 01-02-4962 01-02-5164 01-02-5266
1681 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI/REF Number: 00814193025906/01-02-4254; 00814193025913/01-02-4456; 00814193025920/01-02-4558; 00814193025937/01-02-4760; 00814193025968/01-02-4962; 00814193025944/01-02-5164; 00814193025951/01-02-5266; REF Number/Lot Number: 01-02-4254…
Every code shown here, 1,996 characters
UDI/REF Number: 00814193025906/01-02-4254; 00814193025913/01-02-4456; 00814193025920/01-02-4558; 00814193025937/01-02-4760; 00814193025968/01-02-4962; 00814193025944/01-02-5164; 00814193025951/01-02-5266; REF Number/Lot Number: 01-02-4254 01024254FNN612, 01-02-4254 01024254FNN613, 01-02-4254 01024254GNN614, 01-02-4254 01024254FNN620, 01-02-4254 01024254GNN623, 01-02-4254 01024254FNN644, 01-02-4254 01024254NN651, 01-02-4254 01024254NN652, 01-02-4254 01024254NN741, 01-02-4456 01024456ENN613, 01-02-4456 01024456FNN614, 01-02-4456 01024456ENN620, 01-02-4456 01024456FNN620, 01-02-4456 01024456FNN623, 01-02-4456 01024456ENN644, 01-02-4456 01024456FNN644, 01-02-4456 01024456ENN650, 01-02-4456 01024456FNN650, 01-02-4456 01024456NN651, 01-02-4456 01024456NN652, 01-02-4456 01024456NN656, 01-02-4456 01024456NN728, 01-02-4458 01024458NN651, 01-02-4458 01024458NN652, 01-02-4558 01024558FNN614, 01-02-4558 01024558FNN623, 01-02-4558 01024558NN629, 01-02-4558 01024558HNN686, 01-02-4558 01024558HNN692, 01-02-4558 01024558JNN698, 01-02-4760 01024760FNN614, 01-02-4760 01024760ENN616, 01-02-4760 01024760ENN620, 01-02-4760 01024760FNN620, 01-02-4760 01024760FNN623, 01-02-4760 01024760ENN625, 01-02-4760 01024760FNN644, 01-02-4760 01024760NN651, 01-02-4760 01024760NN652, 01-02-4760 01024760NN654, 01-02-4760 01024760NN656, 01-02-4760 01024760HNN698, 01-02-4760 01024760HNN728, 01-02-4760 01024760HNN741, 01-02-4962 01024962FNN614, 01-02-4962 01024962ENN616, 01-02-4962 01024962FNN622, 01-02-4962 01024962NN624, 01-02-4962 01024962NN628, 01-02-4962 01024962NN645, 01-02-4962 01024962ENN654, 01-02-4962 01024962NN668, 01-02-4962 01024962NN670, 01-02-4962 01024962HNN686, 01-02-4962 01024962HNN723, 01-02-4962 01024962NN734, 01-02-4962 01024962NN735, 01-02-5164 01025164ENN614, 01-02-5164 01025164ENN620, 01-02-5164 01025164ENN622, 01-02-5164 01025164NN634, 01-02-5164 01025164NN649, 01-02-5164 01025164NN656, 01-02-5164 01025164NN669, 01-02-5164 01025164GNN678, 01-02-5164 01025164GNN680, 01-02-5164…
FDA’s list runs to 2,359 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 2,359 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.