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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Ossur H / F: Power Knee and Batteries Recalled Due to Unexpected Shutdown and Fall Risk

Agency Publication Date: January 25, 2024
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Summary

Ossur H / F has recalled approximately 544 Power Knee prosthetic devices and associated batteries because the batteries may fail to turn on or could shut down unexpectedly during use. This defect causes a momentary loss of power to the prosthetic knee, which can result in a loss of physical support for the user. These units were distributed across 41 U.S. states and were initiated following reports that the batteries did not conform to safety standards, which could lead to falls and injuries. Consumers should contact their healthcare provider or the manufacturer to determine if their specific device requires a battery replacement.

Risk

The prosthetic knee may experience a sudden power failure or fail to activate, causing the knee joint to lose its motorized support without warning. This instability can cause the user to lose their balance and fall, potentially resulting in serious physical injury.

What You Should Do

  1. Check the reference and serial numbers on your Power Knee device and battery to see if they match the affected list. This recall includes Power Knee models PKA10001 and PKA10003, and Power Knee Battery model PKA10002.
  2. Verify your specific Knee or Battery serial number against the 544 affected units, such as HF511036, HF551398, HF511050, and many others listed in the product records.
  3. If you identify your device or battery as an affected unit, contact your healthcare provider or prosthetic clinic immediately to arrange for a replacement with a conforming battery.
  4. Contact Ossur H / F directly at their headquarters or through your local distributor to confirm the next steps for receiving a safe replacement battery.
  5. Report any incidents of device failure or injury to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
  6. For additional questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

You have 2 options:

๐Ÿ”„Option 1: Free Replacement

Battery replacement with conforming units

How to: Replacement with conforming batteries to ensure consistent device operation.
๐Ÿ“‹Option 2: Other Action

Manufacturer contact for instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: Power Knee Prosthetic Device (PKA10001)
Model / REF:
PKA10001
UPC Codes:
05690967648381
Lot Numbers (531):
HF511036
HF511050
HF511065
HF511072
HF511081
HF511082
HF511084
HF511096
HF511098
HF511099
HF511104
HF511105
HF511119
HF511121
HF511122
HF511123
HF511124
HF511128
HF511130
HF511131
HF511132
HF511133
HF511136
HF511137
HF511138
HF511139
HF511142
HF511144
HF511148
HF511149
HF511150
HF511151
HF511163
HF511164
HF511165
HF511168
HF511169
HF511170
HF511171
HF511173
HF511178
HF511179
HF511181
HF511182
HF511183
HF511185
HF511187
HF511188
HF511191
HF511192
Product: Power Knee Prosthetic Device (PKA10003)
Model / REF:
PKA10003
UPC Codes:
05690967648749
Lot Numbers:
Refer to PKA10001 serial list
Product: Power Knee Battery (PKA10002)
Model / REF:
PKA10002
UPC Codes:
05690967648404
Lot Numbers (533):
HF551398
HF551935
HF552267
HF551258
HF552479
HF551327
HF552406
HF551301
HF551215
HF551366
HF551409
HF552404
HF551282
HF552298
HF551400
HF552314
HF552333
HF552414
HF552339
HF552315
HF552271
HF552268
HF552316
HF552332
HF552310
HF552483
HF552294
HF551368
HF552401
HF552317
HF552471
HF552251
HF552394
HF552311
HF552470
HF552326
HF551279
HF552309
HF552407
HF551477
HF552485
HF551344
HF552392
HF551347
HF551275/HF552399
HF552290
HF552331
HF552256
HF552249
HF552308

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93549
Status: Active
Manufacturer: Ossur H / F
Sold By: Authorized prosthetic clinics; Medical device distributors
Manufactured In: Iceland
Units Affected: 544 Batteries
Distributed To: Massachusetts, South Carolina, Maryland, Tennessee, North Dakota, Virginia, Illinois, New Jersey, Florida, Michigan, New York, Alabama, Texas, Oklahoma, Indiana, Georgia, California, Pennsylvania, New Mexico, Vermont, Nevada, Mississippi, Hawaii, Ohio, Wisconsin, Louisiana, Iowa, Nebraska, Minnesota, Arkansas, Oregon, North Carolina, New Hampshire, West Virginia, Colorado, Idaho, Arizona, Missouri, Connecticut, Washington, Kentucky, Utah, Kansas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.