NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing,…
Medical device recall Z-1934-2014. Published in FDA’s Enforcement Report on Jul 9, 2014.
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 9, 2014. 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
- 41,180 total 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?
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 4. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
41,180 total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Size 4, includes the following Lot numbers: 370317 37214651 37218726 37219271 37220949 61417419 61417420 61442307 61442308 61442309 61442310 61442311 61450966 61451221 61451222 61459957 61459958 61475125 61475126 61475127 61475128 61488208…
Every code shown here, 1,634 characters
Size 4, includes the following Lot numbers: 370317 37214651 37218726 37219271 37220949 61417419 61417420 61442307 61442308 61442309 61442310 61442311 61450966 61451221 61451222 61459957 61459958 61475125 61475126 61475127 61475128 61488208 61488209 61488210 61488211 61518162 61518163 61518164 61526401 61538046 61543975 61543976 61558363 61567340 61567341 61567342 61567343 61592088 61592089 61627203 61627204 61627205 61627206 61643933 61643934 61658878 61658879 61658880 61658881 61658882 61678232 61678233 61682153 61682154 61682155 61692238 61692240 61721671 61721672 61721673 61774143 61774144 61774145 61774146 61774147 61774148 61827117 61827118 61827119 61863112 61863113 61863114 61863115 61863116 61912438 61914866 61914867 61914868 61914869 61934684 61934685 61934686 61934687 61958859 61958860 61958861 61979028 61979029 61979030 62016156 62016157 62016158 62022554 62022555 62029928 62029929 62029930 62041303 62041304 62060613 62060614 62064935 62064936 62077849 62077850 62077851 62143194 62143195 62143196 62143197 62143604 62143605 62143606 62143607 62168183 62168184 62193304 62193305 62193306 62200285 62200286 62214670 62214671 62214672 62227418 62227419 62261960 62261961 62261962 62261963 62261964 62261966 62315724 62319295 62319296 62319297 62326311 62326312 62332564 62332565 62345558 62345559 62358488 62358490 62363649 62377650 62383363 62383364 62390066 62390067 62390068 62454576 62454577 62454578 62465724 62465725 62465726 62473212 62473213 62473215 62528582 62528583 62586506 62586507 62586509 62586510 62586518 62610915 62610916 62640976 62640977 62640978 62640979 62646146 62646147 62649656 62649658
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 - USA (nationwide) and Internationally to Australia, China, Hong Kong, India, Japan, Korea, Malaysia, Nicaragua, Singapore, and Taiwan.
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 19, 2014.
- FDA classified it on Jun 27, 2014.
- FDA’s Enforcement Report published it on Jul 9, 2014.
- FDA terminated it on Oct 29, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zimmer, 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.