Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components
Medical device recall Z-1478-2020. Published in FDA’s Enforcement Report on Mar 25, 2020.
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 Mar 25, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 24 states named
- 24010 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?
Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos. NN058K NN070K NN071K NN072K NN073K NN074K NN075K NN076K NN077K NN078K NN079K Product Usage:Tibia-Plateaus are part of implants in the group of knee endoprosthetics. For these implant parts there are cemented and cement-free versions as well as versions with zirconium nitride multi layer.
24010, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All product with old packaging configuration. New packaging configuration begins with Lot 52533610. Lots recalled: 51304393 51305032 51308465 51308467 51308475 51308477 51309717 51309718 51309719 51309720 51309721 51309722 51309724…
Every code shown here, 1,996 characters
All product with old packaging configuration. New packaging configuration begins with Lot 52533610. Lots recalled: 51304393 51305032 51308465 51308467 51308475 51308477 51309717 51309718 51309719 51309720 51309721 51309722 51309724 51309725 51309726 51309727 51309728 51309751 51309752 51309753 51309757 51309771 51309772 51311075 51311078 51311083 51312411 51312419 51312426 51312436 51313562 51313563 51313564 51313565 51313566 51313569 51313570 51313797 51314080 51314081 51316258 51316259 51316260 51316281 51316282 51316283 51316288 51316292 51316302 51317871 51317872 51317879 51317882 51317883 51319365 51319376 51319377 51320769 51322218 51322219 51322220 51322241 51322242 51322680 51322708 51323350 51323353 51323354 51323355 51323401 51323402 51324438 51324732 51324733 51324734 51324735 51324736 51324737 51324804 51324805 51324816 51324818 51324820 51324821 51324822 51325086 51325087 51325088 51325089 51325090 51325091 51325092 51325289 51325290 51325291 51325372 51325377 51325378 51325941 51325942 51325944 51325945 51326016 51326441 51326442 51326789 51326790 51326791 51327272 51327273 51327637 51327638 51327639 51327640 51328695 51328696 51328697 51328698 51328777 51329293 51330087 51330141 51330142 51330143 51330144 51330895 51331651 51331652 51331653 51331654 51331877 51331891 51332152 51332153 51332155 51333609 51333610 51333691 51334995 51334996 51334998 51334999 51335000 51335001 51335002 51335485 51335834 51335835 51335942 51336332 51336548 51336552 51336553 51336823 51336824 51336825 51337400 51337690 51337691 51337912 51337914 51338161 51338493 51338494 51338495 51338496 51338498 51338528 51339366 51339619 51340021 51341027 51341028 51341029 51341030 51341033 51341034 51341264 51341265 51341650 51341651 51342012 51342013 51342014 51342672 51342673 51342818 51342819 51342820 51342821 51342823 51343067 51343247 51343248 51343623 51343624 51344141 51344142 51344143 51344144 51344298 51344300 51344676 51345078 51345376 51345377 51346224 51346225 51346227…
FDA’s list runs to 78,549 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.
Worldwide distribution - US Nationwide distribution in the states of AL, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, OH, OK, OR, PA, TN, TX, UT, WA and countries of Saudi Arabia, Utd. Arab Emir., Argentina, Austria, Australia, Bosnia-Herz., Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Cuba, Czech Republic, Germany, Algeria, Ecuador, Estonia, Spain, United Kingdom, Georgia, Greece, Hong Kong, Croatia, Hungary, Indonesia, Ireland, Israel, India, Iraq, Iran, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Libya, Moldavia, Mexico, Malaysia, Nigeria, Netherlands, Poland, Portugal, Paraguay, Russian Fed., Singapore, El Salvador, Thailand, Turkey, Ukraine, South Africa.
The states and territories these words name
24 states and territories.
Every one of them
- Alabama
- California
- Colorado
- Florida
- Georgia
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- North Carolina
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Tennessee
- Texas
- Utah
- Washington
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 Jan 21, 2020.
- FDA classified it on Mar 13, 2020.
- FDA’s Enforcement Report published it on Mar 25, 2020.
- FDA terminated it on Sep 22, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Aesculap Implant Systems LLC, of Center Valley, PA.
- 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 78,549 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.