SpF PLUS-Mini
Medical device recall Z-0287-2019. Published in FDA’s Enforcement Report on Nov 7, 2018.
- FDA Class I
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 Nov 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 46 states named
- 4,879 units (2,982 units have been implanted and 537 have been scrapped) 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
4,879 units (2,982 units have been implanted and 537 have been scrapped), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Item # 10-1398W - SpF Plus - Mini 60/W; Serial Numbers: 409180, 409203, 409209, 409462, 409468, 409474, 409687, 409755, 409760, 409175, 409181, 409204, 409437, 409463, 409469, 409475, 409688, 409756, 409754, 409176, 409182, 409205, 409438,…
Every code shown here, 1,995 characters
Item # 10-1398W - SpF Plus - Mini 60/W; Serial Numbers: 409180, 409203, 409209, 409462, 409468, 409474, 409687, 409755, 409760, 409175, 409181, 409204, 409437, 409463, 409469, 409475, 409688, 409756, 409754, 409176, 409182, 409205, 409438, 409464, 409470, 409476, 409751, 409757, 409686, 409177, 409200, 409206, 409439, 409465, 409471, 409684, 409752, 409758, 409473, 409178, 409201, 409207, 409440, 409466, 409472, 409685, 409753, 409759, 409467, 409179, 409202, 409208, and 409441 Item # 10-1398M - SpFPlus - Mini 60/M; Serial Numbers: 408491, 408743, 408995, 409272, 409544, 409809, 410069, 408490, 408463, 408239, 408492, 408744, 408996, 409273, 409545, 409810, 410070, 408467, 408464, 408240, 408493, 408745, 408997, 409274, 409546, 409811, 410071, 408468, 408465, 408241 408494 408746 408998 409275 409547 409812 410072 408469 408466 408242 408495 408747 408999 409276 409548 409813 410073 408470 408716 408243 408496 408748 409001 409277 409549 409814 410074 408471 408717 408244 408497 408749 409002 409278 409550 409815 410075 408472 408718 408245 408498 408750 409003 409279 409551 409816 410076 408473 408719 408246 408499 408751 409004 409280 409552 409817 410077 408474 408967 408247 408500 408752 409005 409281 409553 409818 410078 408475 408968 408248 408501 408753 409006 409282 409554 409819 410079 408476 408969 408249 408502 408754 409007 409283 409555 409820 410080 408477 408970 408250 408503 408755 409008 409284 409556 409821 410081 408478 409245 408251 408504 408756 409009 409285 409557 409822 410082 408479 409246 408252 408505 408757 409010 409286 409558 409823 410083 408480 409247 408253 408506 408758 409011 409287 409559 409824 410084 408481 409248 408254 408507 408759 409012 409288 409560 409825 410085 408482 409517 408255 408508 408760 409013 409289 409561 409826 410086 408483 409518 408256 408509 408761 409014 409290 409562 409827 410087 408484 409519 408257 408510 408762 409015 409291 409563 409828 410088 408485 409520 408258 408511 408763 409016 409292…
FDA’s list runs to 23,987 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.
US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country of: Australia.
The states and territories these words name
46 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
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 19, 2018.
- FDA classified it on Nov 1, 2018.
- FDA’s Enforcement Report published it on Nov 7, 2018.
- FDA terminated it on Aug 25, 2020.
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 23,987 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.