LFIT Anatomic CoCr Femoral Heads
Medical device recall Z-2296-2018. Published in FDA’s Enforcement Report on Jul 11, 2018.
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 11, 2018. Copied from openFDA on Oct 20, 2026.
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?
The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-140
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 201MJD 20RMJD 20TMED 20XMLE 211MJD 217MKD 21AMKD 21DMKD 21KMJD 21LMKD 21LMKDX1 21VMKD 21WMKD 21WMKDX1 21XMKD 21YMKD 223MAE 234MKE 241MJD 26XMHE 26YMHE 270MHE 280MAE 28TMTD 297MTD 2DDMKE 2DJMJD 2HKMKE 2HNMKE 2JPMKE 2JVMKE 2KKMJD 2MMMAE…
Every code shown here, 1,995 characters
Lots 201MJD 20RMJD 20TMED 20XMLE 211MJD 217MKD 21AMKD 21DMKD 21KMJD 21LMKD 21LMKDX1 21VMKD 21WMKD 21WMKDX1 21XMKD 21YMKD 223MAE 234MKE 241MJD 26XMHE 26YMHE 270MHE 280MAE 28TMTD 297MTD 2DDMKE 2DJMJD 2HKMKE 2HNMKE 2JPMKE 2JVMKE 2KKMJD 2MMMAE 2MPMAE 2MRMAE 2MTMAE 2NAMKE 2VDMAE 2VMMAE 2W6MAE 2W6MJD 2W7MJD 2W8MAE 2WAMJD 2WPMHE 2X5MHE 2XTMAE 2XVMAE 301MHE 30PMAE 30XMJD 30YMJD 315MJD 31NMLE 31PMLE 31RMLE 31TMLE 338MAE 33PMED 33RMED 33TMED 33VMED 33WMED 33XMED 343MED 344MED 345MED 361MRA 361MRAX1 362MRA 8E3MMA 8E3MMAX1 8E4MMA 8E6MMA 8E8MMA 8E8MMAX1 8E9MMA 8ERMMA 8H8MPD 8J8MMA 8L6MPD 8NJMMA 8NJMMAX1 8PLMRA 8PMMRA 8PNMRA 8PNMRAX1 8PTMPD 8PXMPD 8T3MMA 8VPMMA 91AMPE 925MLD 926MLD 934MMA 934MMAX1 93DMMA 953MPA 954MPA 954MPAX1 976MMA 977MMA 978MMA 979MMA 97AMMA 97DMMA 97PMTA 97PMTAX1 97RMTA 97TMTA 97VMTA 97WMTA 99EMPE 99HMPE 9ADMME 9AEMME 9AHMME 9AJMME 9AVMPE 9D5MPE 9DMMPE 9DNMMA 9DPMMA 9DPMMAX1 9DRMPE 9E8MPE 9E9MMA 9E9MMAX1 9E9MMAX1X1 9EEMMA 9EHMMA 9EHMMAX1 9H7MPE 9H9MPE 9L7MPE 9LPMPE 9TJMJD 9TJMJDX1 9TJMJDX2 9V8MJD JH9MJE JHAMJE JHDMJE JHEMJE JHNMPD JHRMED JHRMEDX1 JHVMAE JHWMAE JHXMAE JHYMAE JJ9MLE JKNMDD JKNMDDX1 JKPMAE JKRMAE JLKMDD JLLMDD JLMMDD JLPMDD JLRMDD JLRMDDX1 JLTMDD JLTMDDX1 JLVMDD JLVMDDX1 JMXMHE JN8MPD JN9MPD JNXMED JPRMPD JT2MED JTTMED JVYMED JWXMME JWYMED JWYMEDX1 JX0MME JX1MME JX2MME JX3MED JX4MED JY5MKD JY9MPD K0JMED K2AMHD K5MMJE K66MHD K68MHD K68MHDX1 K78MED K78MEDX1 K7AMED K7DMED K7EMED K7EMJE K7HMED K7HMEDX1 K7HMJE K7JMJE K7KMJE K8WMHD K8XMHD K8XMHDX1 K8YMHD K8YMHDX1 K90MHD K91MHD K91MHDX1 KA1MLE MER718 MERDEP MERDER MERDH8 MERDH9 MERDHA MERDHD MERDHE MERDHEX1 MERDHH MERE2V MERED2 MEREP5 MEREP6 MERHR9 MERHVX MERK77 MERK79 MERK7A MET56M MET56MX1 MET5JX MET5JXX1 MET5JY MET5K0 MET635 MET636 MET637 MET638 MET7DK MET7DKX1 MET7K0 MET7K8 MET7KH MET7KM MET7L9 MET7LJ MET7LM MET7LW MET9Y2 MET9Y3 MET9Y4 METAE4 METAML METARE METATX METATXX1 METATY METATYX1 METAV0 METAVY METAW5 METAWH METAYE METD13 METD13X1 METD20 METD33 METD37 METE6J METE6T METE81 METE82 METE83…
FDA’s list runs to 21,384 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.
Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
These words name no state.
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.
The words say it went outside the United States too.
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 22, 2018.
- FDA classified it on Jul 2, 2018.
- FDA’s Enforcement Report published it on Jul 11, 2018.
- FDA terminated it on May 8, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Howmedica Osteonics Corp., of Mahwah, NJ.
- 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 21,384 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.