Various Knee Systems
Medical device recall Z-0325-2020. Published in FDA’s Enforcement Report on Nov 13, 2019.
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 Nov 13, 2019. 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
- 5,459,583 total devices 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?
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Various Knee Systems, Item Nos. 32855411838 32855411840 32855411842 32855411843 32855420307 32855420308 32855420309 32855420310 32855420315 32855430491 32855430497 32855430499 32855430500 32855430502 32855430503 32855430511 32855430526 32855430530 32855430531 32855430536 32855430537 32855430538 32855430539 32855430541 32855430543 32855430546 32855430548 32855430549 32855430550 32855430551 32855430556 32855430557 32855430558 32855430563 32855430565 32855430567 32855430568 32855430569 32855430570 32855430574 32855430575 32855430577 32855450420 32855450441 32855450453 32855450461 32855450499 32855470626 32855470639 32855470641 32855470644 32855470645 32855470648 32855470649 32855470652 32855470653 32855470654 32855470660 32855470663 32855470666 32855470667 32855470669 32855470672 32855470673 32855470679 32855470680 32855470682 32855470683 32855470684 32855470686 32855470688 32855470689 32855470692 32855470693 32855470694 32855470695 32855470698 32855470699 32855470700 32855470701 32855470704 32855470705 32855470706 32855470707 32855470709 32855470710 32855470712 32855470717 32855470719 32855470721 32855470722 32855470725 32855470726 32855470727 32855470728 32855470729 32855470730 32855470732 32855470733 32855470739 32855470741 32855470742 32855470743 32855470744 32855470745 32855470746 32855470749 32855470750 32855470752 32855470753 32855470761 32855470764 32855470765 32855470766 32855470767 32855470768 32855470769 32855470770 32855470771 32855470772 32855470773 32855470774 32855470775 32855470777 32855470778 32855470779 32855470782 32855470783 32855470785 32855470790 32855470791 32855470801 32855470804 32855470805 32855470806 32855470807 32855470808 32855470809 32855470810 32855470811 32855470813 32855470814 32855470815 32855470816 32855470817 32855470818 32855470825 32855470826 32855470831 32855470843 32855470844 32855470851 32855470856 32855470857 32855470858 32855470859 32855470860 32855470861 32855470862 32855470864 32855470867 32855470875 32855470884 32855470885 32855470900 32855470901 32855470902 32855470905 32855470906 32855470907 32855470908 32855470909 32855470910 32855470911 32855470924 32855470929 32855480907 32855480914 32855480918 32855480928 32855480938 32855480955 32855480993 32855480994 32855480996 32855480997
5,459,583 total devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
All products manufactured prior to January 2014.
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.
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 Oct 10, 2019.
- FDA classified it on Nov 7, 2019.
- FDA’s Enforcement Report published it on Nov 13, 2019.
- FDA terminated it on May 19, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer Biomet, Inc., of Warsaw, IN.
- 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.”
- 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.