Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

ยฉ 2026 Go Backs. All rights reserved.

High RiskFDA Device
Medical Devices/Implants & Prosthetics

Ossur H / F: RHEO KNEE and RHEO KNEE XC Recalled for Firmware Issues and Fall Risk

Agency Publication Date: May 10, 2024
Share:
Sign in to monitor this recall

Summary

Ossur H / F is recalling 251 units of its RHEO KNEE and RHEO KNEE XC prosthetic knees because of firmware defects. These issues can cause the prosthetic device to give unintended warnings or shut down suddenly without notice. This recall includes the RHEO KNEE with 2-year and 3-year warranties, as well as the RHEO KNEE XC with 3-year and 5-year warranties. Consumers were notified of this issue starting in March 2024 through letters sent to affected distributors and patients.

Risk

A firmware error can cause the prosthetic knee to shut down or malfunction during use, leading to a loss of stability. This poses a significant risk of patient falls, which could result in serious injury or bone fractures.

What You Should Do

  1. Check your prosthetic knee's serial number to see if it is affected by this recall. Impacted RHEO KNEE models include serial numbers such as HF377253 1, HF383471, HF383327, HF383283, and many others; impacted RHEO KNEE XC models include serial numbers such as HF366771, HF366854, HF366819, and HF363264.
  2. Identify the specific product version on your warranty or device documentation: RKN130002, RKN130003, RKNXC0003, or RKNXC0005.
  3. If you own an affected device, contact your healthcare provider, prosthetist, or Ossur H / F immediately to receive instructions on necessary firmware updates or further corrective actions.
  4. Be alert for any unintended warning signals or unusual behavior from the device and exercise caution while walking until the device has been serviced.
  5. For further information, contact Ossur H / F at their Reykjavik headquarters or reach out to your local authorized distributor where the device was fitted.
  6. Contact the FDA for additional consumer safety questions at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact healthcare provider or manufacturer for firmware resolution

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

Affected Products

Product: RKN130002, RHEO KNEE 2 YR WARRANTY, External lower limb prosthetic component
Model / REF:
RKN130002
Lot Numbers:
Serial Number: HF377253 1
Product: RKN130003, RHEO KNEE 3 YR WARRANTY, External lower limb prosthetic component
Model / REF:
RKN130003
Lot Numbers (143):
HF383471
HF383327
HF383283
HF366857
HF383410
HF375146
HF365047
HF375188
HF383312
HF375583
HF383377
HF376371
HF383431
HF376550
HF383493
HF376791
HF383276
HF377332
HF383294
HF377766
HF383319
HF378019
HF383346
HF378063
HF383387
HF378251
HF383419
HF378272
HF383437
HF378504
HF383485
HF378508
HF383506
HF378541
HF383273
HF378957
HF383281
HF379043
HF383291
HF379062
HF383310
HF379277
HF383315
HF379328
HF383321
HF379484
HF383342
HF380010
HF383355
HF380230
Product: RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, External lower limb prosthetic component
Model / REF:
RKNXC0003
Lot Numbers (107):
HF366771
HF366854
HF366819
HF363224
HF366748
HF364570
HF366805
HF364686
HF366831
HF365048
HF366880
HF365049
HF366757
HF365311
HF366787
HF365378
HF366815
HF365447
HF366826
HF365546
HF366838
HF365787
HF366874
HF365810
HF362144
HF366081
HF366755
HF366229
HF366759
HF366409
HF366778
HF366647
HF366795
HF366648
HF366811
HF366650
HF366817
HF366651
HF366823
HF366652
HF366828
HF366653
HF366836
HF366659
HF366849
HF366661
HF366860
HF366665
HF366878
HF366672
Product: RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, External lower limb prosthetic component
Model / REF:
RKNXC0005
Lot Numbers:
Serial Number: HF363264

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94332
Status: Active
Manufacturer: Ossur H / F
Sold By: Authorized prosthetic clinics; Specialty healthcare providers
Manufactured In: Iceland
Units Affected: 3 products (143 units; 107 units; 1 unit)
Distributed To: Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming

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.