ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee
Medical device recall Z-0146-2016. Published in FDA’s Enforcement Report on Oct 28, 2015.
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 Oct 28, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 348 units how much, in FDA’s words
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?
May contain small amounts of ethylene glycol residue
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
348 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers (US): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 0354838 0352276 0355506 0355440 0353788 0354652 0349894 0350379 0352905 0354025 0355196 0355405 0355622 0351034 0353474 0353739 0354763…
Every code shown here, 1,993 characters
Serial Numbers (US): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 0354838 0352276 0355506 0355440 0353788 0354652 0349894 0350379 0352905 0354025 0355196 0355405 0355622 0351034 0353474 0353739 0354763 0354158 0355067 0354429 0354764 0353422 0354285 0355646 0355282 0354831 0353993 0355861 0354799 0355519 0353322 0355546 0355319 0355287 0353365 0353987 0355191 0356013 0352467 0354363 0350372 0354462 0355162 0355296 0355070 0354734 0352448 0354116 0353782 0353342 0353040 0355522 0354034 0354476 0354835 0353424 0351578 0353329 0353597 0354408 0354814 0352783 0352940 0352894 0353027 0353492 0352780 0353125 0353929 0353457 0354128 0352830 0354543 0353393 0350374 0353510 0353659 0354329 0354731 0352356 0353996 0353719 0353536 0354611 0353718 0353698 0355577 0355086 0354261 0355369 0352721 0354791 0353907 0354348 0354083 0354913 0353906 0353137 0354217 0355388 0354078 0351433 0353445 0353568 0353678 0355184 0355410 0354357 0354489 0349625 0353344 0354380 0355092 0355190 0355487 0353694 0352789 0355276 0350717 0351645 0351801 0351974 0353200 0353731 0353746 0352301 0353879 0355686 0353555 0352497 0351892 0352645 0353953 0354234 0353091 0353676 0353892 0353525 0353686 0354689 0352675 0352730 0354700 0349501 0354997 0355558 0348201 0354797 0352094 0351889 0353314 0353651 0352070 0353667 0354331 0354949 0354367 0354123 0353835 0354317 0353893 0354935 0353266 0355161 0354833 0353760 0353282 0349733 0352323 0354580 0354704 0349884 0352561 0354060 0353925 0352785 0353414 0354027 0355221 0355347 0355571 0354042 0351810 0351812 0352036 0353837 0353984 0352303 0352740 0354480 0354053 0354093 0356023 0353593 0355366 0354574 0355256 0355218 0353693 0354564 0352800 0353325 0349995 0355358 0353830 0353016 0354368 0354750 0353876 0354153 0353637 0354583 0351816 0350919 0343328 0354482 0355106 0353594 0354469 0355281 0352949 0354302 0355040 0353754 0354253 0355183 0353844 0350226 0350235 0350640 0354839 0353797 0352982 Serial Numbers: OUS 0352548…
FDA’s list runs to 2,824 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 and in Germany, Switzerland, and UK.
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.
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 Aug 31, 2015.
- FDA classified it on Oct 21, 2015.
- FDA’s Enforcement Report published it on Oct 28, 2015.
- FDA terminated it on Mar 2, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ConforMIS, Inc., of Bedford, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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 2,824 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.