Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system
Medical device recall Z-1265-2016. Published in FDA’s Enforcement Report on Apr 6, 2016.
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 6, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Utah the one state its words name
- 890 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?
The anterior/posterior (AP) dimension may be oversized by 0.016 . If the femoral component does not fit as tightly as intended, bony ingrowth may not occur causing loosening of the femoral component. A revision surgery may be necessary.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
890, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Femoral Rt 52.5 105710 195929 Vanguard XP Porous Femoral Rt 52.5 105820 195929 Vanguard XP Porous Femoral Rt 52.5 273570 195929…
Every code shown here, 1,996 characters
Part number; Description; Lot number 195929 Vanguard XP Porous Femoral Rt 52.5 055330 195929 Vanguard XP Porous Femoral Rt 52.5 105710 195929 Vanguard XP Porous Femoral Rt 52.5 105820 195929 Vanguard XP Porous Femoral Rt 52.5 273570 195929 Vanguard XP Porous Femoral Rt 52.5 727260 195929 Vanguard XP Porous Femoral Rt 52.5 727280 195930 Vanguard XP Porous Femoral Rt 55 054980 195930 Vanguard XP Porous Femoral Rt 55 727270 195930 Vanguard XP Porous Femoral Rt 55 727290 195930 Vanguard XP Porous Femoral Rt 55 727310 195930 Vanguard XP Porous Femoral Rt 55 886090 195930 Vanguard XP Porous Femoral Rt 55 961570 195930 Vanguard XP Porous Femoral Rt 55 961580 195931 Vanguard XP Porous Femoral Rt 57.5 054700 195931 Vanguard XP Porous Femoral Rt 57.5 054760 195931 Vanguard XP Porous Femoral Rt 57.5 054990 195931 Vanguard XP Porous Femoral Rt 57.5 055340 195931 Vanguard XP Porous Femoral Rt 57.5 105720 195931 Vanguard XP Porous Femoral Rt 57.5 105730 195931 Vanguard XP Porous Femoral Rt 57.5 105830 195931 Vanguard XP Porous Femoral Rt 57.5 624770 195931 Vanguard XP Porous Femoral Rt 57.5 624940 195932 Vanguard XP Porous Femoral Rt 60 054770 195932 Vanguard XP Porous Femoral Rt 60 054780 195932 Vanguard XP Porous Femoral Rt 60 055000 195932 Vanguard XP Porous Femoral Rt 60 055160 195932 Vanguard XP Porous Femoral Rt 60 105840 195932 Vanguard XP Porous Femoral Rt 60 519250 195932 Vanguard XP Porous Femoral Rt 60 624780 195932 Vanguard XP Porous Femoral Rt 60 624950 195932 Vanguard XP Porous Femoral Rt 60 624960 195932 Vanguard XP Porous Femoral Rt 60 961610 195932 Vanguard XP Porous Femoral Rt 60 961620 195932 Vanguard XP Porous Femoral Rt 60 996930 195933 Vanguard XP Porous Femoral Rt 62.5 054600 195933 Vanguard XP Porous Femoral Rt 62.5 054790 195933 Vanguard XP Porous Femoral Rt 62.5 055010 195933 Vanguard XP Porous Femoral Rt 62.5 055170 195933 Vanguard XP Porous Femoral Rt 62.5 055350 195933 Vanguard XP Porous Femoral Rt 62.5 105850 195933 Vanguard XP Porous Femoral Rt…
FDA’s list runs to 10,884 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.
UT Netherlands
The states and territories these words name
- Utah
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 5, 2016.
- FDA classified it on Mar 25, 2016.
- FDA’s Enforcement Report published it on Apr 6, 2016.
- FDA terminated it on Mar 28, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- 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 10,884 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
-
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.