LFIT Anatomic CoCr Femoral Heads
Medical device recall Z-2297-2018. 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. 6260-9-144
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 869MPA 869MPAX1 87PMKD 8A3MKD 8A3MKDX1 8ARMRD 8DTMKD 8EVMRD 8EVMRDX1 8KRMPA 8KRMPAX1 8M2MRD 8RVMRD 8TDMPA 8TDMPAX1 8TTMPD 8V6MPD 8V9MPD 8V9MPDX1 8VVMPD 8X1MPD 900MPD 913MPD 938MPD 938MPDX1 94JMLD 94YMPA 94YMPAX1 94YMPAX2 9LHMLD 9M3MLD…
Every code shown here, 1,997 characters
Lots 869MPA 869MPAX1 87PMKD 8A3MKD 8A3MKDX1 8ARMRD 8DTMKD 8EVMRD 8EVMRDX1 8KRMPA 8KRMPAX1 8M2MRD 8RVMRD 8TDMPA 8TDMPAX1 8TTMPD 8V6MPD 8V9MPD 8V9MPDX1 8VVMPD 8X1MPD 900MPD 913MPD 938MPD 938MPDX1 94JMLD 94YMPA 94YMPAX1 94YMPAX2 9LHMLD 9M3MLD 9R2MAD 9R2MADX1 9R4MAD 9R5MAD 9R5MLA 9R6MAD 9R7MAD 9R7MADX1 9RMMLA 9RYMLA 9RYMLAX1 9TEMLA 9V9MRA 9VAMRA 9VDMRA 9VDMRAX1 9VEMRA 9YYMPD 9YYMPDX1 A00MPD A00MPDX1 A08MPD A09MPD A09MPDX1 A2EMEE A2HMEE A2JMEE A2KMEE A4DMLD A53MEE A5AMLA A5DMLA A5HMLA A6XMEE A77MLD A94MEE AA1MLD AA2MTA AA2MTAX1 MHDY1K MHDY28 MHDY28X1 MHDY2D MHE0N7 MHE0TW MHE0W3 MHE0W3X1 MHE0WL MHE10K MHE10X MHE118 MHE11A MHEKK3 MHEKME MHEKVT MHEKVTX1 MHEKW5 MHEKW5X1 MHEL3L MHEL3Y MHEL3YX1 MHEL4D MHEL4R MHEL4RX1 MHEL80 MHEL80X1 MHEL8D MHEL8DX1 MHELD9 MHELD9X1 MHELK6 MHEM74 MHH4EX MHH4EXX1 MHH4LW MHH4W7 MHH514 MHH53R MHH549 MHH54A MHH54D MHH54E MHH55W MHH55WX1 MHH55X MHH5DR MHH5DRX1 MHJ1N0 MHJ235 MHJ237 MHJ26D MHJ26E MHJ28T MHJ2H9 MHJ2KM MHJ2MM MHJKJM MHJKJV MHJKK3 MHJKK5 MHJLAH MHJLEM MHJLJ8 MHJLPN MHJLR4 MHJM1X MHJM37 MHJM4J MHJM4Y MJKNMH MJKPAP MJKPAR MJKPAV MJKPAW MJKPHP MJKPHR MJKPHT MJKPHW MJKPLA MJKPLD MJKPLE MJKPLH MJKR11 MJKR12 MJKVNW MJKVNX MJKVNY MJKVP0 MJKWT7 MJKWT9 MJKWTA MJKWTD MJKX1A MJKX1D MJKX1E MJKX1H MJL33T MJL45Y MJL68K MJL8PJ MJLH0V MJLH65 MJLHDR MJLL6Y MJLN33 MJLP37 MJLP88 MJLV6J MJM0HD MJM93L MJMER8 MJMHXP MJMJT3 MJMK4A MJMLJ8 MJMLRT MJMM18 MJMPWP MJMR45 MJMRJV MJMRTD MJMTD6 MJMVAV MJMX9K MJMYTM MJN2T2 MJN72M MJN93E MJN9K1 MJNAKE MJNEAV MJNEWA MJNJJX MJNJVJ MJNK7K MJNLE9 MJNREV MJP1N2 MJP1NH 009MJE 00AMJE 021MME 0D7MDE 0NXMLA 0P1MLA 0PHMLA 0PNMLA 0PXMLA 0RAMLA 0X9MDE 0X9MDEX1 0XAMDE 0XDMDE 109MMA 109MMAX1 10AMMA 10AMMAX1 10DMMA 10EMMA 10PMMA 116MJD 117MJD 118MJD 119MJD 11AMJD 11DMJD 11EMJD 11HMJD 127MME 128MME 129MME 12TMPE 12XMDE 12YMDE 130MDE 131MDE 13LMLA 13LMLAX1 AA3MTA AA4MTA AA4MTAX1 AA5MTA ALRMLD ALWMLD AT3MKD AT4MKD AT5MKD AT5MKDX1 AVYMKD AW0MKD AW1MKD AX6MKD AXMMKD AXXMKD D2MMKD D2MMMA D2MMMAX1 D2RMMA D30MMA D3AMMD D3DMMD D3DMMDX1 D3EMMD…
FDA’s list runs to 6,917 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 6,917 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.