Hearth Record

SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030,…

Medical device recall Z-0671-2024. Published in FDA’s Enforcement Report on Jan 17, 2024.

FDA’s own record, on accessdata.fda.gov

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 Jan 17, 2024. Copied from openFDA on Oct 20, 2026.

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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037

898 units, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

REF: 17V1030/UDI: (01)04035459407045/ Order #s 877130 871608 869477 873755 873408 873462 872532 871154 880168 880929 865865 873716 866700 870221 871517 875929 877106 877351 871959 875613 866847 882306 881541 869191 869393 875444 872004…

Every code shown here, 1,999 characters

REF: 17V1030/UDI: (01)04035459407045/ Order #s 877130 871608 869477 873755 873408 873462 872532 871154 880168 880929 865865 873716 866700 870221 871517 875929 877106 877351 871959 875613 866847 882306 881541 869191 869393 875444 872004 867991 880396 868574 877787 876488 879697 866838 875675 877656 867391 873489 869196 872232 870921 867678 868728 877709 867990 879513 869349 869864 880431 879922 882026 872429 876236 871997 881374 880275 876177 869274 870606 879926 871392 878189 869601 867903 876762 867908 867780 873752 867175 872533 879230; REF: 17V2030/UDI: (01)04035459407038/ Order #s: 873689 877130 873755 873462 872532 880168 877383 881065 865865 873716 871519 875929 867520 875141 875160 867907 874430 879427 877351 875613 866847 871613 873697 874810 875444 879594 882000 867991 880396 880970 868574 868353 876488 866838 867391 873489 873231 869196 872232 876230 870921 867678 873227 877571 868728 877709 879513 869864 876395 880173 869459 872429 869390 868305 876236 880312 871997 881374 869931 870606 875391 876579 867903 876762 881372 872533 873878 879230; Ref: 17V1031/UDI: (01)04035459407069/ Order #s: 869376 877592 868548 876410 878842 881809 880881 877660 876614 882052 879617 872834 882487 878021 879707 885211 873387 876483 869443 870617 879042 880962 872482 878416 880911 866671 869932 875859 879015 879025 879592 880159 880964 876760 879612 880877 871624 866854 880364 869861 878403 871982 873934 881784 875842 879494 871626 881116 871383 880615 867163 880906 873012 879916 872027 874269 879786 869348 869509 877134 868540 869454 870916 877470 869449 870345 876431 879886 869492 871615 871474 871983 874858 870224 880370 875734 879805 884301 877916 875650 881023 870863 881420 870976 881627 871168 873674 873378 873382 874252 880193 877172 871371 881427 879725 873968 875137 880850 881995 872026 871100 874324 878077 879796 880217 873603; REF: 17V2031/UDI: (01)04035459407052/Order #s: 870883 869376 877592 876410 878842 876357 876638 866839 880881 877660 874924 867409 878010…

FDA’s list runs to 5,274 characters. The first part is shown; the rest is on FDA’s record.

Source:

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: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA QC SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico, OUS: None OUS: Canada, New Zealand, Japan, Australia, Netherlands, United Kingdom

The states and territories these words name

48 states and territories.

Every one of them
  • Alabama
  • Arkansas
  • Arizona
  • California
  • Colorado
  • Connecticut
  • District of Columbia
  • Delaware
  • Florida
  • Georgia
  • Iowa
  • Idaho
  • Illinois
  • Indiana
  • Kansas
  • Kentucky
  • Louisiana
  • Massachusetts
  • Maryland
  • Maine
  • Michigan
  • Minnesota
  • Missouri
  • Mississippi
  • Montana
  • North Carolina
  • Nebraska
  • New Hampshire
  • New Jersey
  • New Mexico
  • Nevada
  • New York
  • Ohio
  • Oklahoma
  • Oregon
  • Pennsylvania
  • Puerto Rico
  • South Carolina
  • South Dakota
  • Tennessee
  • Texas
  • Utah
  • Virginia
  • Vermont
  • Washington
  • Wisconsin
  • West Virginia
  • Wyoming

The words say it went outside the United States too.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Is it still going on?

Completed, in FDA’s file.

“The recall action reaches the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.”

openFDA, on “Completed”, its enforcement report fields.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

  • The firm began the recall on Sep 23, 2023.
  • FDA classified it on Jan 5, 2024.
  • FDA’s Enforcement Report published it on Jan 17, 2024.
Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Who is recalling it?

  • Townsend Design, of Bakersfield, CA.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: E-Mail.
Source:

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 5,274 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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