LFIT Anatomic CoCr Femoral Heads
Medical device recall Z-2295-2018. 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. 6260-9-136
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 13461301 13461302 14097201 14097202 14390101 14390102 14814301 14934401 14941101 14973401 15029001 15029002 15186801 15186802 15186803 15341401 15341402 15341403 15341404 15629401 15629402 15759601 16462601 16551101 16551102 16575601…
Every code shown here, 1,996 characters
Lots 13461301 13461302 14097201 14097202 14390101 14390102 14814301 14934401 14941101 14973401 15029001 15029002 15186801 15186802 15186803 15341401 15341402 15341403 15341404 15629401 15629402 15759601 16462601 16551101 16551102 16575601 16575602 16644801 16666901 16684501 17159001 17159002 17230201 17230202 18077901 18110901 18110902 18110903 18216001 18216002 18216003 18298901 18298902 18744901 18748501 18748502 18783701 18783702 18783703 19122001 19122002 19362201 19362401 19362501 19362601 19506201 19506202 19549601 19549602 19634101 19634102 19634103 19634104 19691001 19691002 19696801 19696802 19696803 19716501 19719801 22400903 22400904 22402901 22407101 22648401 22648402 22648403 22740701 22740702 22740703 22740704 22740705 22775201 22775202 22775203 22775204 22775205 22817801 23434501 23434502 23434503 23471701 23516001 23516002 23516003 23542801 23542802 23542803 24109201 24122901 24142401 24142402 24205901 24205902 24268901 24268902 24282401 24297601 24806101 24806102 24867301 24867401 24941701 25290501 25290502 25344001 25344002 25360701 25369201 25369202 25369203 25447801 25447802 25447803 26147701 26147702 26195101 26195102 26195103 26205301 26205302 26205303 26290001 26290002 26306101 26380701 27257501 27304201 27304202 27304203 86149403 86149404 86149405 86296301 86296302 86296303 86375901 86375902 86375903 86375904 86375905 86466301 86466302 88966401 88966402 88966403 89044301 89446101 89840201 89840202 90405301 90405302 91124201 91124202 91797901 91797902 91797903 92501201 92501202 92501203 92501301 92993801 92993802 92993803 93418201 93418202 93418203 93982801 93982802 94499901 94499902 95178201 95178202 95178203 95501301 95501302 95821201 95821202 95821203 96419601 96419602 96419603 96419604 96837401 96837402 96837403 97136401 97136402 97338901 97338902 98094401 98426601 98426602 98883501 98883502 99063401 99063402 99350201 99350202 000MPA 20484207X1 20484207X1X1 20484207X2 20484208X1 20547701X1 20547702X1 20547703X1 20547703X1X1 20547703X2…
FDA’s list runs to 37,252 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 37,252 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.