EcoFit cup cementless
Medical device recall Z-2050-2021. Published in FDA’s Enforcement Report on Jul 21, 2021.
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 Jul 21, 2021. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 41 units (U.S.) 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?
A risk exists during impacting of the acetabular cup into the bone the plugs may come loose from the cup, which could lead to operation duration extension or revision operation. A warning note is being added to instructions for use and surgical technique alerting users that the quality of bone in the patient (such as osteosclerosis) is an attributable factor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
EcoFit cup cementless: Model(Catalog Number)/Description: 02200046 /EcoFit cup cementless 46mm dia incl. central hole cover; 02200048 /EcoFit cup cementless 48mm dia incl. central hole cover; 02200050 /EcoFit cup cementless 50mm dia incl. central hole cover; 02200052 /EcoFit cup cementless 52mm dia incl. central hole cover; 02200054 /EcoFit cup cementless 54mm dia incl. central hole cover; 02200056 /EcoFit cup cementless 56mm dia incl. central hole cover; 02200058 /EcoFit cup cementless 58mm dia incl. central hole cover; 02200060 /EcoFit cup cementless 60mm dia incl. central hole cover; 02200062 /EcoFit cup cementless 62mm dia incl. central hole cover; 02200064 /EcoFit cup cementless 64mm dia incl. central hole cover; 02200066 /EcoFit cup cementless 66mm dia incl. central hole cover; 02200068 /EcoFit cup cementless 68mm dia incl. central hole cover;
41 units (U.S.), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Instructions for Use Reference Number: ECOCUOPU and Surgical Technique Reference Number:09300038US Model(Catalog Number)/Description: 02200046 /EcoFit¿ cup cementless ¿ 46mm incl. central hole cover; UDI: 04048844005368 Lot Numbers:…
Every code shown here, 1,997 characters
Instructions for Use Reference Number: ECOCUOPU and Surgical Technique Reference Number:09300038US Model(Catalog Number)/Description: 02200046 /EcoFit¿ cup cementless ¿ 46mm incl. central hole cover; UDI: 04048844005368 Lot Numbers: 1736252001; 1736252003; 1736252004; 1736252006; 1736252007; 1736252008; 1736252010; 18481C0027; 18481C0010; 18481C0004; 18481C0013; 18481C0005; 18481C0024; 02200048 /EcoFit¿ cup cementless ¿ 48mm incl. central hole cover; UDI: 04048844005375 Lot Numbers: 17420NM001 17420NM002 17420NM003 17420NM005 17420NM007 17420NM010 17420NM011 17420NM012 17420NM013 17420NM014 17420NM015 17420NM016 17420NM018 17420NM019 17420NM020 17420NM021 17420NM022 17420NM023 17420NM025 17420NM026 02200050 /EcoFit¿ cup cementless ¿ 50mm incl. central hole cover; UDI: 04048844005382 Lot Numbers: 174111N008 174111N012 174111N018 190414M002 190414M003 190414M004 190414M012 190414N016 174111N002 174111N005 174111N006 174111N013 174111N022 174111N023 174111N026 190625J027 190625J026 190625J028 190625J009 190625J012 190625J014 190625J021 190625J020 190625J001 190625J017 190625J006 190625J002 190625J004 190625J018 02200052 /EcoFit¿ cup cementless ¿ 52mm incl. central hole cover; UDI: 04048844005399 Lot Numbers: 1736253002 1736253005 1736253007 1736253008 1736253015 1736253016 1736253017 1736253021 1736253004 1736253006 1736253014 1736253019 1736253020 1736253022 1736253023 190909E021 190909E005 190909E014 190909E004 190909E017 190909E025 190909E002 190909E018 190909E023 190909E006 190909E009 190909E001 02200054 /EcoFit¿ cup cementless ¿ 54mm incl. central hole cover; UDI: 04048844005405 Lot Numbers: 1748194005 1748194007 1748194008 1748194011 1748194013 1748194016 1748194022 1748194023 1748194025 1748194026 1748194001 1748194003 1748194006 1748194012 1748194017 1748194018 1748194020 1748194028 1849208014 1849208004 1849208012 185019I006 1849208001 1849208006 185019I004 1849208009 02200056 /EcoFit¿ cup cementless ¿ 56mm incl. central hole cover; UDI: 04048844005412 Lot…
FDA’s list runs to 3,819 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.
U.S. Nationwide distribution in the states of FL and TX.
The states and territories these words name
- Florida
- Texas
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 10, 2021.
- FDA classified it on Jul 9, 2021.
- FDA’s Enforcement Report published it on Jul 21, 2021.
- FDA terminated it on Nov 18, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- IMPLANTCAST GMBH, of Buxtehude, Germany.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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 3,819 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
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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.