RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 05690967595418/ Serial Numbers: 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 HF383384 HF380398 HF383395 HF380403 HF383412 HF380450 HF383426 HF380510 HF383434 HF381405 HF383445 HF381419 HF383482 HF381429 HF383488 HF381443 HF383503 HF381512 HF383509 HF381970 HF383268 HF382159 HF383274 HF382314 HF383279 HF382346 HF383282 HF382371 HF383285 HF382395 HF383292 HF382481 HF383309 HF382878 HF383311 HF383192 HF383314 HF383193 HF383316 HF383194 HF383320 HF383195 HF383322 HF383196 HF383328 HF383198 HF383344 HF383200 HF383352 HF383210 HF383376 HF383216 HF383383 HF383218 HF383385 HF383219 HF383388 HF383220 HF383396 HF383221 HF383411 HF383222 HF383413 HF383224 HF383421 HF383230 HF383427 HF383234 HF383433 HF383237 HF383435 HF383238 HF383444 HF383239 HF383454 HF383240 HF383472 HF383241 HF383483 HF383243 HF383486 HF383244 HF383491 HF383245 HF383494 HF383246 HF383504 HF383262 HF383507 HF383264 HF383532 HF383266 HF383267
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Ossur H / F
- Reason for Recall:
- Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Product Codes/Lot Numbers:
UDI: 05690967595418/ Serial Numbers: 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 HF383384 HF380398 HF383395 HF380403 HF383412 HF380450 HF383426 HF380510 HF383434 HF381405 HF383445 HF381419 HF383482 HF381429 HF383488 HF381443 HF383503 HF381512 HF383509 HF381970 HF383268 HF382159 HF383274 HF382314 HF383279 HF382346 HF383282 HF382371 HF383285 HF382395 HF383292 HF382481 HF383309 HF382878 HF383311 HF383192 HF383314 HF383193 HF383316 HF383194 HF383320 HF383195 HF383322 HF383196 HF383328 HF383198 HF383344 HF383200 HF383352 HF383210 HF383376 HF383216 HF383383 HF383218 HF383385 HF383219 HF383388 HF383220 HF383396 HF383221 HF383411 HF383222 HF383413 HF383224 HF383421 HF383230 HF383427 HF383234 HF383433 HF383237 HF383435 HF383238 HF383444 HF383239 HF383454 HF383240 HF383472 HF383241 HF383483 HF383243 HF383486 HF383244 HF383491 HF383245 HF383494 HF383246 HF383504 HF383262 HF383507 HF383264 HF383532 HF383266 HF383267
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1788-2024
Related Recalls
Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.
Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient falls.