Hearth Record

LFIT Anatomic CoCr Femoral Heads

Medical device recall Z-2293-2018. Published in FDA’s Enforcement Report on Jul 11, 2018.

FDA’s own record, on accessdata.fda.gov

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.

Source:

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.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

Lots 586MTA 587MTA 588MTA 588MTAX1 589MTA 5E8MMD 5E9MMD 5EAMMD 5HDMDE 5JKMMD 5JKMMDX1 5L9MPA 5LHMPA 5LJMPA 5LVMPA 5LVMPAX1 5LWMPA 5LXMPA 5MPMTD 5MRMTD 5MRMTDX1 5R0MND 5TDMMD 5V1MND 5V7MHD 5VHMHD 5VTMHD 5W0MHD 5WEMHD 5WKMHD 5WNMHD 5WTMHD…

Every code shown here, 1,996 characters

Lots 586MTA 587MTA 588MTA 588MTAX1 589MTA 5E8MMD 5E9MMD 5EAMMD 5HDMDE 5JKMMD 5JKMMDX1 5L9MPA 5LHMPA 5LJMPA 5LVMPA 5LVMPAX1 5LWMPA 5LXMPA 5MPMTD 5MRMTD 5MRMTDX1 5R0MND 5TDMMD 5V1MND 5V7MHD 5VHMHD 5VTMHD 5W0MHD 5WEMHD 5WKMHD 5WNMHD 5WTMHD 5WVMAE 5WXMAE 5WYMAE 5X0MAE 60RMAE 61DMME 61EMME 61HMME 61HMND 61JMME 61KMDE 61LMDE 61LMDEX1 61MMDE 62HMND 62HMNDX1 62LMMD 63YMAD 63YMADX1 640MAD 641MAD 642MAD 650MDE 65NMMD 662MMD 662MND 665MND 68PMMD 690MED 691MED 692MED 693MED 69DMTD 6A9MTD 6ARMAD 6HNMMD 6HYMAD 6J2MAD EJAMHE EJTMME EJVMME EK2MME EKLMDD EL3MME ENNMRD ETTMPA ETXMPA EVLMDD EXRMRD EXTMRA EXVMRA EXVMRAX1 EY1MRD H0PMHE H0RMDD H0TMTD H0VMTD H0WMTD H0XMTD H0YMTD H16MDD H16MDDX1 H21MHE H36MJE H36MJEX1 H37MJE H38MJE H39MJE H3HMHE H50MRD H51MRD H52MRD H79MHE H90MTD H91MTD H92MTD H9RMTD H9TMTD HH6MHE HHLMMA HHLMMAX1 HHMMMA HHNMMA HHPMMA HHRMMA HHRMMAX1 HJ4MAE HJ5MAE HJ6MAE HJ7MAE HL6MMA HL7MMA HL7MMAX1 HM7MHE HMWMHE HP9MJE HPEMJE HPHMJE HPKMJE HT6MLA HT8MLA HT9MLA HV5MHE HV7MME HV8MME HV9MME HVAMME HVEMRA METHA2 METHAH METHAHX1 METHAJ METHAK METHD3 METHD4 METHDD METMPD METMRL METMRM METMVP METMWM METMXW METMY2 METMY6 METMYE MHA754 MHA755 MHA756 MHA757 MHA8WA MHA8WE MHA8WH MHA8WHX1 MHA8WJ MHAHVH MHAHW2 MHAJ1W MHAJ89 MHAJM0 MHAJM2 MHAJP3 MHAJP4 MHAJP7 MHAJW9 MHAJX9 MHAK18 MHAK18X1 MHAK2L MHAK4L MHAK6R MHANH1 MHANK3 MHANPT MHANX5 MHAP0D MHAP19 MHAP42 MHAP87 MHAPAY MHAPDD MHAPDE MHAPDEX1 MHAPH4 MHDJR8 MHDK8H MHDK8K MHDK8L MHDK8M MHDK8N MHDK8P MHDK8R MHDK8T MHDK8V MHDLAE MHDLAW MHDLDL MHDLDX MHDLEP MHL76M MHL76N MHL76P MHL7NA MHL7ND MHL7NE MHL8AK MHL8E4 MHL8E6 MHL8E7 MHL8EW MHL8EX MHL8HW MHL8LN MHL8V6 MHL8WR MHL8WT MHL8WV MHL8WW MHL97M MHL9KV MHL9V7 MHL9VP MHL9VT MHL9W2 MHL9WD MHL9WE MHL9X3 MHL9X5 MHL9X6 MHLA6Y MHLA70 MHLA72 MHLA73 MHLA74 MHLAWP MHLD04 MHLD06 MHLD13 MHLD14 MHLD15 MHLD23 MHLD24 MHLD2W MHLD3E MHLD3H MHLD3J MHLD3K MHLD3L MHLD3M MHLDTL MHLDXD MHLDXE MHLE23 MHMNM5 MHMNM5X1 MHMNV0 MHMNWL MHMNXD MHMNXE MHMNXP MHMNYA MHMP1D MHMP43 MHMP5W MHMP9D MHMP9DX1 MHMPA6 MHMPD7…

FDA’s list runs to 13,747 characters. The first part is shown; the rest is on FDA’s record.

Source:

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.

Source:

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.

Source:

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.
Source:

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.
Source:

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 13,747 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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