various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage…
Medical device recall Z-1861-2017. Published in FDA’s Enforcement Report on Apr 26, 2017.
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 Apr 26, 2017. 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
- 28,253 in 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?
Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
various polyethylene implants Knees Revision Tibial Tray Systems Oxford Partial Knee Orthopedic Salvage System Vanguard Complete Knee System Vanguard SSK Revision System Biomet Patella Maxim Complete Knee System Biomet Series A Patella Vanguard 360 Revision System Vanguard Deep Dish Rotating Platform Biomet CP Bearings Product Usage: For use in total knee arthroplasty. Limb salvage joint reconstruction. Partial knee replacement.
28,253 in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481…
Every code shown here, 1,998 characters
Items and lots: Item 141261 598890 Item 141262 501720 781540 Item 141263 466300 516170 516190 Item 141264 466430 516220 516230 516240 584590 609910 Item 141265 466440 527490 609920 684740 Item 141266 584620 Item 141268 527590 Item 141481 412820 920390 Item 141482 289810 412870 805950 920410 Item 141483 537790 Item 141484 412920 903910 Item 141485 920420 Item 141512 781920 781960 805970 Item 141514 806010 Item 141515 827960 Item 150410 241990 373830 596750 Item 150411 231200 373840 373850 Item 150412 129940 231210 231220 596910 Item 150413 129950 Item 150414 409730 Item150415 129960 596920 Item 150476 510910 510930 510940 Item 150477 780710 780720 780730 780750 780760 Item 150478 240650 576750 576760 576770 576780 Item 159540 347930 373920 373940 456340 456350 545520 545530 Item 159541 341160 347940 347950 456370 456380 Item 159542 373970 442290 528600 Item 159543 293050 444990 Item 159544 347970 Item 159547 374010 456390 545540 661660 Item 159548 374020 374030 374040 456420 456430 545550 545560 661690 661710 877470 877480 Item 159549 176330 374050 528610 528620 582170 Item 159550 242070 374060 582190 Item 159551 293130 374080 Item 159552 374090 Item 159554 456460 661720 661730 707890 747790 747810 Item 159555 528650 528670 582240 917610 Item 159556 582270 Item 159557 582290 Item 159558 374190 Item 159562 374200 Item 159563 270530 Item 159564 456470 Item 159566 374210 Item 159568 341230 374220 374240 545570 545580 Item 159569 348040 348110 348120 374250 374260 917620 Item 159570 445000 445010 528740 Item 159571 348140 456520 Item 159575 374300 374320 374330 456530 456550 456560 545610 545620 Item 159576 170280 374350 374370 456570 545630 545640 661760 661780 Item 159577 170420 293190 374290 374420 528750 582360 582380 Item 159578 374430 Item 159579 456590 Item 159580 528760 Item 159582 456600 456610 661810 661830 661840 Item 159583 445020 445030 528780 Item 159584 528790 Item 159586 528810 Item 159592 445070 Item 159593 528830 Item 159595 170310 445080 Item 159790…
FDA’s list runs to 12,442 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 - US Nationwide in the ARGENTINA AUSTRALIA CANADA CHILE CHINA COSTA RICA ECUADOR GSCC INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO PANAMA Singapore SWITZERLAND THAILAND 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.
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 Feb 17, 2017.
- FDA classified it on Apr 18, 2017.
- FDA’s Enforcement Report published it on Apr 26, 2017.
- FDA terminated it on Jan 29, 2018.
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.”
- FDA’s list of codes runs to 12,442 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.