Vanguard 360 Revision Knee System Knee prostheses
Medical device recall Z-0003-2017. Published in FDA’s Enforcement Report on Oct 12, 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 Oct 12, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 9 states named in where it went
- 454 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 drill bit used to drill the hex pre-drilled hole in the screw head of the Tibial Augment Bolts included in the Vanguard 360 Revision Knee System was larger than allowable per the process specification. As a result, the hex geometry can still be visible, but there are radial cuts into the hex flat. Therefore, when the bolt is inserted into the augment, the screwdriver is unable to catch on the hex geometry, or the screwdriver strips the remaining hex geometry, and the bolt is unable to be fully tightened. The bolt stripping or the bolt not being fully tightened will be noticed by the surgeon intraoperatively when he or she is unable to screw the augment bolts into the augment. This possible event can result in an intraoperative delay resulting in increased time under anesthesia.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Vanguard 360 Revision Knee System Knee prostheses
454, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
ITEM LOT DESCRIPTION 185220 262690 BMT 360 TIB AUG 59X5MM 185221 475560 BMT 360 TIB AUG 63X5MM 185222 262720 BMT 360 TIB AUG 67X5MM 185222 475570 BMT 360 TIB AUG 67X5MM 185222 524160 BMT 360 TIB AUG 67X5MM 185222 690770 BMT 360 TIB AUG…
Every code shown here, 1,995 characters
ITEM LOT DESCRIPTION 185220 262690 BMT 360 TIB AUG 59X5MM 185221 475560 BMT 360 TIB AUG 63X5MM 185222 262720 BMT 360 TIB AUG 67X5MM 185222 475570 BMT 360 TIB AUG 67X5MM 185222 524160 BMT 360 TIB AUG 67X5MM 185222 690770 BMT 360 TIB AUG 67X5MM 185223 421690 BMT 360 TIB AUG 71X5MM 185223 475580 BMT 360 TIB AUG 71X5MM 185223 475590 BMT 360 TIB AUG 71X5MM 185223 524170 BMT 360 TIB AUG 71X5MM 185224 475600 BMT 360 TIB AUG 75X5MM 185224 475610 BMT 360 TIB AUG 75X5MM 185224 524180 BMT 360 TIB AUG 75X5MM 185224 647840 BMT 360 TIB AUG 75X5MM 185224 690790 BMT 360 TIB AUG 75X5MM 185225 342740 BMT 360 TIB AUG 79X5MM 185225 421700 BMT 360 TIB AUG 79X5MM 185225 524190 BMT 360 TIB AUG 79X5MM 185225 524200 BMT 360 TIB AUG 79X5MM 185225 690800 BMT 360 TIB AUG 79X5MM 185226 647850 BMT 360 TIB AUG 83X5MM 185226 751570 BMT 360 TIB AUG 83X5MM 185228 647910 BMT 360 TIB AUG 91X5MM 185228 751420 BMT 360 TIB AUG 91X5MM 185230 524210 BMT 360 TIB AUG 59X10MM 185231 421730 BMT 360 TIB AUG 63X10MM 185231 475620 BMT 360 TIB AUG 63X10MM 185231 524220 BMT 360 TIB AUG 63X10MM 185232 377450 BMT 360 TIB AUG 67X10MM 185232 377460 BMT 360 TIB AUG 67X10MM 185232 421750 BMT 360 TIB AUG 67X10MM 185232 475630 BMT 360 TIB AUG 67X10MM 185232 524230 BMT 360 TIB AUG 67X10MM 185233 342750 BMT 360 TIB AUG 71X10MM 185233 377470 BMT 360 TIB AUG 71X10MM 185233 475640 BMT 360 TIB AUG 71X10MM 185233 524240 BMT 360 TIB AUG 71X10MM 185234 262780 BMT 360 TIB AUG 75X10MM 185234 262790 BMT 360 TIB AUG 75X10MM 185234 524250 BMT 360 TIB AUG 75X10MM 185235 421770 BMT 360 TIB AUG 79X10MM 185235 421780 BMT 360 TIB AUG 79X10MM 185237 229750 BMT 360 TIB AUG 87X10MM 185238 229760 BMT 360 TIB AUG 91X10MM 185238 262820 BMT 360 TIB AUG 91X10MM 185239 511390 BMT 360 TIB AUG BOLT 10MM 185241 148190 BMT 360 TIB AUG 63X15MM RL/LM 185242 969710 BMT 360 TIB AUG 67X15MM RL/LM 185243 377480 BMT 360 TIB AUG 71X15MM RL/LM 185247 262750 BMT 360 TIB AUG 87X15 RL/LM 185250 421790 BMT 360 TIB AUG 59X15MM LL/RM 185251 262770 BMT 360 TIB AUG…
FDA’s list runs to 2,841 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 Distribution - US Distribution to the states of : VA, UT, TX. OR, MN, AL, PA, CA and KY., and to the countries of : AUSTRALIA, China, Italy, Netherlands and Japan.
The states and territories these words name
- Alabama
- California
- Kentucky
- Minnesota
- Oregon
- Pennsylvania
- Texas
- Utah
- Virginia
The words say it went outside the United States too.
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 Aug 8, 2016.
- FDA classified it on Oct 3, 2016.
- FDA’s Enforcement Report published it on Oct 12, 2016.
- FDA terminated it on Jun 5, 2017.
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 2,841 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.