ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee
Medical device recall Z-0145-2016. 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
- 313 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 (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee Catalog Number: M57250600010 (US) M5725INT0600010 (OUS)
313 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers (US): 0348488 0355066 0355392 0355317 0353561 0354483 0354945 0355261 0355989 0347842 0355561 0351297 0354882 0354343 0354746 0356253 0355288 0351033 0354279 0354994 0352643 0353878 0354579 0353642 0353612 0353882 0352852…
Every code shown here, 1,993 characters
Serial Numbers (US): 0348488 0355066 0355392 0355317 0353561 0354483 0354945 0355261 0355989 0347842 0355561 0351297 0354882 0354343 0354746 0356253 0355288 0351033 0354279 0354994 0352643 0353878 0354579 0353642 0353612 0353882 0352852 0354051 0355244 0354198 0353638 0355030 0354485 0352979 0355292 0354752 0354992 0354915 0355643 0355534 0354406 0354834 0355706 0353989 0355877 0355175 0352628 0354616 0354740 0353368 0352993 0354481 0354768 0355262 0355375 0353458 0355484 0355865 0336962 0355154 0353183 0353452 0352902 0353126 0353139 0353927 0354087 0353911 0355624 0355128 0354275 0354378 0352822 0353001 0353300 0353327 0352113 0354712 0354918 0354813 0353104 0353705 0352746 0353487 0354216 0353915 0354542 0354690 0354875 0354151 0354522 0355219 0355499 0351896 0351998 0354374 0354730 0354923 0354800 0353898 0354486 0354056 0354952 0354213 0354342 0353964 0353717 0354837 0353406 0355368 0354941 0347736 0353823 0353827 0353465 0353595 0354174 0354492 0355152 0352954 0353203 0354649 0354365 0355158 0355492 0353546 0351478 0352263 0352265 0353735 0353747 0352455 0353472 0353990 0352910 0354442 0355491 0354477 0353848 0350752 0349020 0354936 0353182 0353910 0355258 0352741 0354222 0354224 0354314 0355354 0355457 0353524 0354129 0354537 0353495 0354822 0351981 0353313 0354333 0354928 0354897 0353656 0354006 0354090 0355187 0354122 0353983 0354546 0354934 0354002 0353397 0355160 0354304 0354581 0352577 0353030 0354254 0353046 0352985 0354874 0355129 0354026 0355346 0355431 0355570 0355220 0353002 0351811 0352037 0352376 0354614 0351800 0354185 0354248 0355733 0354270 0354105 0352799 0355126 0352886 0354038 0355498 0353395 0352788 0354249 0354080 0354152 0354751 0353317 0353468 0353654 0353473 0354188 0353326 0354473 0352906 0349619 0352571 0353360 0353426 0354015 0354307 0354101 0353652 0353869 0355010 0355698 0352948 0353559 0352380 0354650 0352891 0348392 0350639 0353181 Serial Numbers: OUS 0350255 0354385 0353821 0354323 0351187 0354283 0353298 0353715 0348897…
FDA’s list runs to 2,544 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 2,544 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.