RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
Medical device recall Z-1825-2014. Published in FDA’s Enforcement Report on Jun 25, 2014.
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 25, 2014. 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
- 175 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?
Ability Dynamics is recalling RUSH81 Prosthetic Foot because the existing bolts may be bottomed out in the threaded hole and this could lead to bolt failure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
RUSH81 Prosthetic Foot Product Usage: Prosthetic foot for human use
175 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: B1400045 B1400085 B1400272 B1400352 B1400101 B1400344 B1300083 B1400133 B1400114 B1300030 B1400290 B1400297 B1400197 B1400305 B1300043 B1400264 B1300080 B1400024 B1400087 B1300073 B1400108 B1400330 B1400138 B1300056…
Every code shown here, 1,680 characters
Serial Numbers: B1400045 B1400085 B1400272 B1400352 B1400101 B1400344 B1300083 B1400133 B1400114 B1300030 B1400290 B1400297 B1400197 B1400305 B1300043 B1400264 B1300080 B1400024 B1400087 B1300073 B1400108 B1400330 B1400138 B1300056 B1400261 B1400210 B1400321 B1400337 B1400300 B1400323 B1400351 B1400103 B1400104 B1400156 B1400173 B1400202 B1400222 B1400232 B1400253 B1400269 B1300062 B1400296 B1400258 B1400083 B1400111 B1300084 B1400135 B1400294 B1400031 B1400036 B1400162 B1300082 B1400102 B1400050 B1400051 B1400076 B1400084 B1300038 B1300025 B1400288 B1400280 B1400281 B1400312 B1400018 B1400252 B1400245 B1400260 B1400128 B1400201 B1400215 B1400308 B1400071 B1400033 B1400058 B1400213 B1400196 B1400214 B1400203 B1400204 B1400115 B1400212 B1400144 B1400319 B1400238 B1300072 B1300074 B1400336 B1400335 B1300061 B1400174 B1400175 B1400171 B1400194 B1300050 B1400059 B1400025 B1300036 B1400074 B1400089 B1400234 B1400346 B1400010 B1300065 B1400055 B1400064 B1300048 B1400151 B1400066 B1400090 B1400118 B1400119 B1400147 B1300029 B1300064 B1400227 B1400230 B1400231 B1400152 B1400153 B1300032 B1400216 B1400239 B1400241 B1400242 B1300075 B1400020 B1400298 B1400311 B1300023 B1400338 B1400340 B1400134 B1400143 B1400005 B1400289 B1300060 B1400105 B1400225 B1400332 B1400141 B1400154 B1400043 B1400098 B1400181 B1400318 B1400223 B1400220 B1400339 B1400182 B1400268 B1400334 B1300026 B1400049 B1400046 B1400047 B1400052 B1400249 B1400027 B1300047 B1300051 B1300053 B1400155 B1400310 B1400160 B1300079 B1300066 B1400015 B1400350 B1400273 B1400185 B1400250 B1400322 B1400061 B1300035 B1400168 B1300004 B1300005 B1300009 B1300010 B1300014 B1300015 B1300016 B1300020 B1400270 B1400271
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) and in the countries of Australia and Canada.
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 Jun 2, 2014.
- FDA classified it on Jun 18, 2014.
- FDA’s Enforcement Report published it on Jun 25, 2014.
- FDA terminated it on Sep 22, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ability Dynamics LLC, of Tempe, AZ.
- 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.”
- 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.