RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Summary
The FDA issued a Class II for RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic compo by Ossur H / F. Reason: Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in patient fall.
Details
Source
Device Recall
External ID
Z-1788-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
Lot/Code Info: 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
Quantity Affected: 143 units
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.
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-25
Company
Reykjavik, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ossur H / F has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ossur H / F) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ossur H / F have FDA actions?
Ossur H / F has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1788-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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