LFIT Anatomic CoCr Femoral Heads, 6260-9-036
Medical device recall Z-2292-2018. 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, 6260-9-036
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 10176601 10176602 10446901 10852601 10937801 11121001 11121002 11969801 11969802 12204501 12204502 12204503 12668301 12668302 12668303 13365101 13365102 13365103 14101701 14101702 14390201 14390202 15186701 15186702 15186703 15292201…
Every code shown here, 2,000 characters
Lots 10176601 10176602 10446901 10852601 10937801 11121001 11121002 11969801 11969802 12204501 12204502 12204503 12668301 12668302 12668303 13365101 13365102 13365103 14101701 14101702 14390201 14390202 15186701 15186702 15186703 15292201 15341301 15629301 15759301 16462501 16575502 16637001 16666801 16684301 17158901 17158902 17230301 17230302 18133801 18133802 18133803 18216101 18216102 18216103 18783601 18783602 19313601 19313602 19313603 19313604 19506101 19506102 19549501 19549502 19614801 19614802 19614803 19691301 19691302 19715701 19738101 19738102 19738103 19780201 19780202 19843901 19843902 20167601 20479101 20479102 35007304 35246401 35826901 35826902 35826903 35826904 35826905 36140401 36140402 36140403 36140404 36140405 36467201 36467202 36467203 36467204 36993801 37014601 37014602 37014603 37014604 37014605 37034301 37034302 37252501 37252502 37252503 37367101 37367102 37367103 37367104 37708901 37708902 37708903 37708904 38044501 38044502 38044503 38044504 38044505 38044506 38287401 38287402 38287403 38287404 87530201 87530202 87530203 87530204 87530205 87530501 87530502 87530503 87530504 87535501 87544601 90469601 90469602 92059101 92059102 92059103 92059104 92677301 92677302 93490501 93490502 93639401 93639501 93982601 93982602 36LMKA 374MKA 37KMMD 37PMTD 37RMTD 37TMTD 38449701C 38449702C 38449703X 38449704C 38449705C 394MKA 39JMMD 3AHMNE 3AVMNE 3AWMNE 3AWMNEX1 3JYMNA 3K3MNA 3KDMNA 3KDMNAX1 3KKMNA 3KKMNAX1 3MDMHD 3MJMMD 3NWMNE 3P2MHA 3P4MHA 3P5MHA 3P6MHA 3P7MHA 3PLMKD 3PPMKD 3T4MKD 3WJMMD 400MNE 401MNE 426MMD 42EMMD 438MHD 43LMTD 43MMTD 43NMTD 451MHD 47LMHD 48JMHD 48PMHD 49AMPD 4D6MHE 4D7MHE 4D8MHE 4V5MPE 4V5MPEX1 4VDMPD 4VDMPDX1 4WLMPE 4XJMKD 4XLMKD 4YPMKD 539MPE 53MMPD 53NMPD 57NMPE 59KMMD 59LMMD 59VMJE 5A1MKD 5A5MJE 5A7MJE 5K6MPE DTVMJD DYPMKE E16MDD E63MPD E6HMND E6LMPD E6LMPDX1 E6WMPD E6WMPDX1 E6YMND E7HMDD E7KMDD E7KMDDX1 E7LMDD E92MTA E93MTA E94MTA E95MTA E95MTAX1 EHRMNE EJ0MAE EJ4MAE EVDMAE EVLMNE EWJMMD H2XMAE H30MAE H31MAE HARMTD HARMTDX1…
FDA’s list runs to 20,008 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 20,008 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.