OSSUR Power Knee
Medical device recall Z-1821-2022. Published in FDA’s Enforcement Report on Oct 5, 2022.
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 Oct 5, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 36 states named
- 190 devices 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?
Battery may dislodge from the Power Knee
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T
190 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number / UDI-DI Code PKA10001 / 05690967648381 Serial Numbers: HF511081; HF511095; HF511100; HF511102; HF511116; HF511133; HF511323; PKA10003 / 05690967648749 Serial Numbers: HF511029 HF511036 HF511042 HF511050 HF511060 HF511061…
Every code shown here, 1,999 characters
Model Number / UDI-DI Code PKA10001 / 05690967648381 Serial Numbers: HF511081; HF511095; HF511100; HF511102; HF511116; HF511133; HF511323; PKA10003 / 05690967648749 Serial Numbers: HF511029 HF511036 HF511042 HF511050 HF511060 HF511061 HF511065 HF511070 HF511071 HF511072 HF511075 HF511077 HF511082 HF511084 HF511096 HF511098 HF511099 HF511101 HF511104 HF511105 HF511108 HF511110 HF511115 HF511119 HF511121 HF511122 HF511123 HF511124 HF511126 HF511127 HF511128 HF511130 HF511131 HF511132 HF511136 HF511137 HF511138 HF511142 HF511144 HF511146 HF511148 HF511149 HF511151 HF511155 HF511159 HF511162 HF511163 HF511164 HF511165 HF511168 HF511169 HF511170 HF511171 HF511173 HF511176 HF511178 HF511179 HF511181 HF511182 HF511183 HF511185 HF511187 HF511188 HF511191 HF511192 HF511193 HF511194 HF511195 HF511198 HF511199 HF511200 HF511201 HF511204 HF511206 HF511207 HF511208 HF511212 HF511213 HF511216 HF511217 HF511218 HF511219 HF511221 HF511222 HF511223 HF511224 HF511225 HF511227 HF511228 HF511229 HF511230 HF511231 HF511234 HF511235 HF511236 HF511244 HF511245 HF511246 HF511247 HF511248 HF511250 HF511251 HF511253 HF511254 HF511255 HF511256 HF511257 HF511259 HF511260 HF511261 HF511262 HF511263 HF511264 HF511265 HF511267 HF511268 HF511269 HF511270 HF511274 HF511276 HF511277 HF511278 HF511279 HF511280 HF511281 HF511282 HF511283 HF511285 HF511286 HF511287 HF511293 HF511294 HF511295 HF511296 HF511298 HF511299 HF511300 HF511301 HF511302 HF511303 HF511306 HF511307 HF511308 HF511309 HF511311 HF511313 HF511314 HF511315 HF511318 HF511320 HF511321 HF511322 HF511325 HF511326 HF511327 HF511328 HF511338 HF511339 HF511340 HF511341 HF511342 HF511344 HF511345 HF511347 HF511348 HF511349 HF511350 HF511351 HF511352 HF511355 HF511356 HF511358 HF511360 HF511361 HF511362 HF511366 HF511367 HF511368 HF511369 HF511370 HF511372 HF511373 HF511376 Note - These Models below are Loaner devices and are under Firm’s control PKA01001L / 05690967642822 Serial Numbers: HF511037 HF511091 HF511324 HF511143 HF511363 HF511375…
FDA’s list runs to 2,320 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.
U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI.
The states and territories these words name
36 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Florida
- Georgia
- Hawaii
- Iowa
- Illinois
- Indiana
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Virginia
- Vermont
- Washington
- Wisconsin
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 Aug 29, 2022.
- FDA classified it on Sep 28, 2022.
- FDA’s Enforcement Report published it on Oct 5, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ossur Americas, of Foothill Ranch, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
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 2,320 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.