Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Medical device recall Z-0788-2024. Published in FDA’s Enforcement Report on Jan 31, 2024.
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 31, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 43 states named
- 544 Batteries 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?
Knee batteries may need replacement with conforming batteries to ensure there isn’t a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
544 Batteries, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
REF/UDI-DI: PKA10001/05690967648381, PKA10003/05690967648749, PKA10002/05690967648404. Knee/Battery Serial Numbers: HF511036 HF551398, HF511050 HF551935, HF511065 HF552267, HF511072 HF551258, HF511081 HF552479, HF511082 HF551327, HF511084…
Every code shown here, 1,996 characters
REF/UDI-DI: PKA10001/05690967648381, PKA10003/05690967648749, PKA10002/05690967648404. Knee/Battery Serial Numbers: HF511036 HF551398, HF511050 HF551935, HF511065 HF552267, HF511072 HF551258, HF511081 HF552479, HF511082 HF551327, HF511084 HF552406, HF511096 HF551301, HF511098 HF551215, HF511099 HF551366, HF511104 HF551409, HF511105 HF552404, HF511119 HF551282, HF511121 HF552298, HF511122 HF551400, HF511123 HF552314, HF511124 HF552333, HF511128 HF552414, HF511130 HF552339, HF511131 HF552315, HF511132 HF552271, HF511133 HF552268, HF511136 HF552316, HF511137 HF552332, HF511138 HF552310, HF511139 HF552483, HF511142 HF552294, HF511144 HF551368, HF511148 HF552401, HF511149 HF552317, HF511150 HF552471, HF511151 HF552251, HF511163 HF552394, HF511164 HF552311, HF511165 HF552470, HF511168 HF552326, HF511169 HF551279, HF511170 HF552309, HF511171 HF552407, HF511173 HF551477, HF511178 HF552485, HF511179 HF551344, HF511181 HF552392, HF511182 HF551347, HF511183 HF551275/HF552399, HF511185 HF552290, HF511187 HF552331, HF511188 HF552256, HF511191 HF552249, HF511192 HF552308, HF511193 HF551346, HF511194 HF552284, HF511195 HF551216, HF511198 HF552241, HF511199 HF551321, HF511200 HF552335, HF511201 HF552260, HF511242 HF551226, HF511257 HF552327, HF511267 HF552277, HF511277 HF552305, HF511278 HF552325, HF511279 HF552245, HF511280 HF552323, HF511281 HF552255, HF511282 HF552328, HF511283 HF552296, HF511293 HF551406, HF511294 HF551380, HF511295 HF552487, HF511296 HF552408, HF511298 HF551413, HF511299 HF552299, HF511302 HF551399, HF511303 HF552264, HF511306 HF551337, HF511307 HF552337, HF511308 HF552248, HF511309 HF552340, HF511311 HF552263, HF511313 HF552307, HF511314 HF552261, HF511315 HF552478, HF511318 HF552475, HF511319 HF552280, HF511320 HF552324, HF511321 HF552312, HF511322 HF552320, HF511323 HF552259, HF511325 HF551389, HF511326 HF551218, HF511327 HF551367, HF511328 HF552301, HF511339 HF552322, HF511341 HF552286, HF511342 HF552473, HF511344 HF551527, HF511345 HF551223, HF511347…
FDA’s list runs to 10,341 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 including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS.
The states and territories these words name
43 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- 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.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Dec 26, 2023.
- FDA classified it on Jan 25, 2024.
- FDA’s Enforcement Report published it on Jan 31, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ossur H / F, of Reykjavik, Iceland.
- 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 10,341 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.