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RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

FDA Device Recall #Z-1788-2024 — Class II — March 25, 2024

Recall Summary

Recall Number Z-1788-2024
Classification Class II — Moderate risk
Date Initiated March 25, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Ossur H / F
Location Reykjavik, N/A
Product Type Devices
Quantity 143 units

Product Description

RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

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 Pattern

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.

Lot / Code Information

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

Other Recalls from Ossur H / F

Recall # Classification Product Date
Z-0006-2025 Class II Miami J Select Collar, Catalog: MJS-101; Miami ... Aug 20, 2024
Z-1789-2024 Class II RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, ... Mar 25, 2024
Z-1787-2024 Class II RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, Ext... Mar 25, 2024
Z-1790-2024 Class II RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, ... Mar 25, 2024
Z-0788-2024 Class II Power Knee, REF: PKA10001, and PKA10003; with P... Dec 26, 2023

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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