LFIT Anatomic CoCr Femoral Heads
Medical device recall Z-2294-2018. 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. 6260-9-044
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 3P9MKE 3PEMKE 3PHMKE 3PJMKE 3PKMKE 3XJMKE 3XKMKE 44EMJD 44HMJD 44JMJD 46NMRA 46PMRA 46PMRAX1 46RMRA 485MJD 487MJD 488MJD 48AMJD 48EMJD 4A5MJD 4A5MJDX1 4DYMHE 4E2MHE 4E3MHE 4E4MHE 4KPMTD 4Y2MTD 4Y3MTD 4Y4MTD 54KMJD 54LMJD 54MMJD 67VMLE…
Every code shown here, 1,997 characters
Lots 3P9MKE 3PEMKE 3PHMKE 3PJMKE 3PKMKE 3XJMKE 3XKMKE 44EMJD 44HMJD 44JMJD 46NMRA 46PMRA 46PMRAX1 46RMRA 485MJD 487MJD 488MJD 48AMJD 48EMJD 4A5MJD 4A5MJDX1 4DYMHE 4E2MHE 4E3MHE 4E4MHE 4KPMTD 4Y2MTD 4Y3MTD 4Y4MTD 54KMJD 54LMJD 54MMJD 67VMLE 6D7MLE 6DPMLE 6DXMLE 6K3MKE 6LHMKE 6LLMKE 6LMMKE 6LNMKE 6NMMKE 6R1MKE 7AJMRA 7AJMRAX1 7AKMRA 7AKMRAX1 803MMD 805MMD 806MMD 807MMD 807MMDX1 80AMMD 80DMMD 85MMPA 85NMPA 85PMPA 8J0MPA 8Y6MRD 918MRD 91RMRD 92XMND 939MND 93HMND 94VMPA 94XMPA 94XMPAX1 9JMMRD 9KKMRD 9T3MPD MHH6ML MHH6VE MHH728 MHJ39H MHJ3JR MHJ3K9 MHJ3NE MHK4AJ MHK4RV MHK53A MHK53E MHK54J MHK54K MHK5AD MHK5DJ MHKL67 MHKL7R MHKLP2 MHKLP4 MHKLTD MHKLTE MHKLVL MHKLWD MHKLXJ MHKM15 MHKME5 MHKMT6 MHKMY0 MHKN2A MHKN4T MHKN70 MHKND1 MHKNR0 MHKNR6 MHKNRX MHKNTY MHKNV0 MHKNV1 MHLPVJ MHLR02 MHLR0D MHLR0J MHLR0L MHLR4J MHLR60 MHLR61 MHLR62 MHLRK5 MHLRTL MHLRTP MHLRTT MHLRTW MHLT13 MHLT3J MHLT3L MHLT4P MHLT51 MHLT82 MHLT83 MHLT84 MHLT85 MHN2YM MHN316 MHN35M MHN3EH MHP421 MHP422 MHP424 MHP425 MHP426 P65MPD P66MPD PA1MDE PAWMDE PNVMLA PNYMLA PP0MLA PP1MLA PP2MLA PVTMMA PVVMMA PVWMMA R3KMMA R3RMMA R3RMMAX1 R3XMMA R3XMMAX1 R4TMMA R4TMMAX1 R4VMMA RHEMLA RHJMLA RHKMLA RHKMLAX1 RHKMLAX1X1 RHLMLA RHLMLAX1 RHMMLA RHNMLA RHNMLAX1 RHPMLA RNYMME RP3MMA RPWMME RPXMME RPYMME RTRMMA RV4MMA RV4MMAX1 RV5MMA RV6MMA RV7MMA VJ7MLE VJ8MLE W8PMLE X5AMLE X8LMLE 0H4MLA 0H4MLAX1 0KKMMA 0KKMMAX1 0KKMMAX1X1 0KLMMA 0KMMMA 0KPMMA 0KRMMA 0KRMMAX1 0KVMJE 0L9MJE 0M5MLA 0TWMMA 0TXMMA 0TYMMA 0V0MMA 0V1MMA 0V1MMAX1 0WXMRA 0WYMRA 0X0MRA 0X2MRA 14EMDE 14HMDE 14JMDE 14KMDE 155MJE 157MJE 158MJE 1JLMJE 262MHD 263MHD 265MHD 266MHD 267MHD 268MHD 269MHD 2NDMKE 2NEMKE 2NHMKE 2NJMKE 325MAE 336MAE 35HMHD 35HMHDX1 35JMHD 376MAE 379MKE 3E4MAE 3HMMKE 3JRMNE 3JTMNE 3JVMNE 3JWMNE 3L1MKE 3M5MKE 3N1MKE 3N2MKE 3NMMJD 3NPMJD 3NTMJD 3NYMJD 3P0MJD 3P1MJD 3P2MJD 3P2MKE 3P3MJD 3P5MJD 3P7MJD MER6XA MER6XAX1 MER6YE MHA3K9 MHA3L5 MHA3L7 MHA3LA MHA3RP MHA3RR MHA3RT MHA3RV MHA3RW MHA4KX MHA4KY MHA4M2 MHA4M3 MHA4PJ MHA4PK MHA4PL MHA4PM MHA4PN…
FDA’s list runs to 4,948 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 4,948 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.