LFIT Anatomic CoCr Femoral Heads
Medical device recall Z-2298-2018. 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. 6260-9-336
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lots 20864103 20864104 20904401 20904402 20904403 20904404 20934901 21035401 21035402 21035403 21035404 21035405 21164901 21164902 21164903 21164904 21505801 21505802 21505803 21505804 21505805 21686801 21686802 21686803 21686804 21686805…
Every code shown here, 1,996 characters
Lots 20864103 20864104 20904401 20904402 20904403 20904404 20934901 21035401 21035402 21035403 21035404 21035405 21164901 21164902 21164903 21164904 21505801 21505802 21505803 21505804 21505805 21686801 21686802 21686803 21686804 21686805 21724101 21724102 22380201 22380202 22380203 22380204 22428103 22428104 22428106 22697601 22697602 22697603 23500101 23500102 23500103 24173601 24269101 24808501 24876201 25290901 25290902 25407001 25448001 26147901 26147902 26380901 27250601 27374701 27374702 27374703 28238601 28281901 28287801 28341901 28341902 29161501 29161502 29273501 30198401 30198402 30198403 30311101 30536301 30536302 92677202A 927MME 92AMME 92DMME 948MME 96419801A 9AKMPE 9D2MPE 9D2MPEX1 9D3MPE 9HLMDA 9HMMDA 9HNMDA A32MLA A33MLA A8HMHA A8VMHA A8XMHA AERMJE AL4MEE AL5MEE AL7MEE AMPMRD ANNMJE AXLMPD AXLMPDX1 D1TMJE D44MPD D45MPD D45MPDX1 D6LMRD D72MRD D79MRD D79MRDX1 E24MHA H0TMKA HH8MKA HH8MKAX1 HHXMLD HJMMMD HJMMMDX1 HT6MKA HTMMKA HTYMKA J00MMD J4LMLE J4PMLE J6KMND J7DMDE J7DMDEX1 J9MMDE J9NMDE J9RMDE JEVMTD JK6MTD JK6MTDX1 JK7MTD JK8MTD JK8MTDX1 JLKMAE JM6MAE JM6MAEX1 JM7MAE JM7MAEX1 JTDMPA K1EMMD K44MJA K4NMJA K52MJA KALMMD MHR91M MHR93E MHT7HT MHT7WY MHT89A MHT8A0 MHT8AL MHT8JN MHT8KA MHT8LL MHT958 MHT99L MHT9A8 MHT9AT MJ3MPD MJ3MPDX1 MJA840 MJA8W4 MJA9LT MJA9TA MJAA07 MJAAD2 MJAAEH MJAR9T MJAR9V MJAR9X MJAR9Y MJARA0 MJARA1 MJARA2 MJAT1H MJAT1J MJAT1K MJAT1L MJE7NP MJE80N MJE81M MJE8HE MJE8LK MJE8M5 MJE8M6 MJETP3 MJETP4 MJETP5 MJEV2X MJEV2Y MJEV30 MJEW00 MJEW61 MJEWD0 MJH669 MJH6E2 MJH6E3 MJHHK3 MJHHK9 MJHHKE MJHHXD MJHHXE MJHHXH MJHJ3J MJHJ3M MJHJ3N MJJ1JD MJJ1L5 MJJ1PV MJJE7A MJJE8M MJJEE4 MJJEMA MJJER9 30671301 30671302 30926601 31338101 31338102 32773301 32773302 33187001 33187002 33652401 33652402 33652403 33678201 33678202 33678203 33678204 34786901 34786902 35085701 35101601 35909101 35909102 35921801 36202101 36202102 36492101 36492102 37063501 37063502 37205901 37221001 37613401 37613402 37613403 37613404 38004501 38004502 38004503 38271101…
FDA’s list runs to 6,840 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 6,840 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.