Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left…
Medical device recall Z-2155-2020. Published in FDA’s Enforcement Report on Jun 3, 2020.
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 Jun 3, 2020. 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
- 105 units 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?
Potential presence of elevated endotoxin levels that exceed the specification limit
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154705 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 US154707 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 US154713 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 US154719 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 US154720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 US154721 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 US154723 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154731 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 US154735 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154746 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 US154734 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 US154730 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 Product Usage: Knee prosthesis
105 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Numbers: UDI Number 570440 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 (01)00880304180703(17)211219(10)570440 548700 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left…
Every code shown here, 1,995 characters
Lot Numbers: UDI Number 570440 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 (01)00880304180703(17)211219(10)570440 548700 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 (01)00880304180833(17)211219(10)548700 560400 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 (01)00880304180864(17)211221(10)560400 630710 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 (01)00880304180666(17)211223(10)630710 570430 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 (01)00880304180680(17)211226(10)570430 690010 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 (01)00880304180741(17)211220(10)690010 560370 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 (01)00880304180802(17)211226(10)560370 630720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 (01)00880304180819(17)211226(10)630720 548690 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 (01)00880304180826(17)211227(10)548690 560390 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 (01)00880304180840(17)211227(10)560390 570450 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 (01)00880304180864(17)211223(10)570450 548720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 (01)00880304180888(17)211226(10)548720 560410 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 (01)00880304180888(17)211227(10)560410 697350 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 (01)00880304180925(17)211223(10)697350 615650 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray,…
FDA’s list runs to 3,015 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 Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.
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 Apr 17, 2020.
- FDA classified it on May 28, 2020.
- FDA’s Enforcement Report published it on Jun 3, 2020.
- FDA terminated it on Jun 25, 2021.
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 3,015 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.