Vanguard Total Knee System Vanguard Open Box Femoral Components
Medical device recall Z-1115-2017. Published in FDA’s Enforcement Report on Feb 8, 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 Feb 8, 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
- 15,000 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?
packaging of some femoral components was incorrectly labeled as either smaller or larger and/or as the incorrect side (right/left). Risk delay in surgery.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Vanguard Total Knee System Vanguard Open Box Femoral Components Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Item Number: 183104 Description: VNGD PS OPEN INTL FEM RT 60 Item Number: 183106 Description: VAN PS OPEN INTL FEM-RT 62.5 Item Number: 183108 Description: VAN PS OPEN INTL FEM-RT 65 Item Number: 183110 Description: VAN PS OPEN INTL FEM-RT 67.5 Item Number: 183112 Description: VAN PS OPEN INTL FEM-RT 70 Item Number: 183113 Description: VAN PS OPEN INTL FEM-RT 72.5 Item Number: 183120 Description: VAN PS OPEN INTL FEM-LT 55 Item Number: 183122 Description: VAN PS OPEN INTL FEM-LT 57.5 Item Number: 183124 Description: VAN PS OPEN INTL FEM-LT 60 Item Number: 183126 Description: VAN PS OPEN INTL FEM-LT 62.5 Item Number: 183128 Description: VAN PS OPEN INTL FEM-LT 65 Item Number: 183130 Description: VAN PS OPEN INTL FEM-LT 67.5 Item Number: 183132 Description: VAN PS OPEN INTL FEM-LT 70 Item Number: 183133 Description: VAN PS OPEN INTL FEM-LT 72.5
15,000, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Lot Numbers: J3762496 J3762510 J3778480 J3786204 J3803291 J3812133 J3825051 J3833214 J3838037 J3844255 J3848989 J3762497 J3772688 J3779265 J3786205 J3803292 J3812134 J3825052…
Every code shown here, 1,995 characters
Item Number: 183100 Description: VNGD PS OPEN INTL FEM RT 55 Lot Numbers: J3762496 J3762510 J3778480 J3786204 J3803291 J3812133 J3825051 J3833214 J3838037 J3844255 J3848989 J3762497 J3772688 J3779265 J3786205 J3803292 J3812134 J3825052 J3833215 J3844243 J3844256 J3848991 J3762498 J3773147 J3779266 J3786206 J3807380 J3818045 J3826948 J3833216 J3844244 J3844257 J3848992 J3762500 J3773148 J3781773 J3786207 J3807381 J3818046 J3826949 J3834846 J3844246 J3844258 J3848993 J3762501 J3773149 J3781774 J3786209 J3808161 J3818047 J3826950 J3834847 J3844247 J3844259 J3762502 J3775073 J3781775 J3803285 J3808162 J3819257 J3826951 J3834848 J3844248 J3844260 J3762504 J3775074 J3781777 J3803286 J3810188 J3823556 J3826952 J3834849 J3844250 J3847164 J3762506 J3775075 J3781778 J3803287 J3812129 J3823557 J3826954 J3838032 J3844251 J3847165 J3762507 J3775076 J3781779 J3803288 J3812130 J3823558 J3826958 J3838033 J3844252 J3847166 J3762508 J3778478 J3781781 J3803289 J3812131 J3823559 J3830022 J3838034 J3844253 J3848987 J3762509 J3778479 J3786202 J3803290 J3812132 J3823560 J3830023 J3838035 J3844254 J3848988 Item Number: 183102 Description: VNGD PS OPEN INTL FEM-RT 57.5 Lot Numbers: J3747463 J3769382 J3778412 J3789356 J3803324 J3824927 J3829964 J3834871 J3842063 J3844275 J3849012 J3750117 J3770471 J3778413 J3792510 J3803325 J3824928 J3829965 J3834872 J3842064 J3844276 J3849013 J3751073 J3770473 J3778414 J3792511 J3803326 J3824929 J3829966 J3834873 J3842065 J3844277 J3849014 J3753286 J3770474 J3779264 J3792512 J3803327 J3824931 J3830619 J3834874 J3842066 J3844278 J3851751 J3753287 J3770475 J3781782 J3792513 J3812135 J3824932 J3830620 J3834875 J3842067 J3844279 J3851752 J3753290 J3772632 J3781783 J3792514 J3815876 J3824933 J3830622 J3834876 J3842068 J3844281 J3851753 J3753293 J3772633 J3783564 J3794919 J3815877 J3824935 J3830623 J3834877 J3844261 J3844282 J3851754 J3753294 J3773111 J3783565 J3794920 J3815878 J3824936 J3830624 J3834878 J3844262 J3844283 J3851755 J3754883 J3773112 J3783566…
FDA’s list runs to 35,531 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.
NATIONWIDE US ARGENTINA AUSTRALIA AUSTRIA BRAZIL CANADA CHILE CHINA COSTA RICA ECUADOR GREECE INDIA ITALY JAPAN KOREA, THE REP OF (SOUTH) MALAYSIA MEXICO NETHERLANDS PANAMA POLAND SINGAPORE THAILAND
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 Jan 4, 2017.
- FDA classified it on Jan 28, 2017.
- FDA’s Enforcement Report published it on Feb 8, 2017.
- FDA terminated it on Jun 11, 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 35,531 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.