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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94332

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 25, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ossur H / F

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component

Z-1787-2024
Recall number
Z-1787-2024
Initiated
March 25, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ossur H / F
Quantity
N/A

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI: 05690967598426/ Serial Number: HF377253 1

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.

device · product 2 of 4

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

Z-1788-2024
Recall number
Z-1788-2024
Initiated
March 25, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ossur H / F
Quantity
143 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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

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.

device · product 3 of 4

RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component

Z-1789-2024
Recall number
Z-1789-2024
Initiated
March 25, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ossur H / F
Quantity
107 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI: 05690977467804/ Serial Numbers: 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 HF366893 HF366673 HF366738 HF366678 HF366754 HF366680 HF366756 HF366681 HF366758 HF366690 HF366762 HF366692 HF366775 HF366693 HF366782 HF366696 HF366793 HF366697 HF366802 HF366698 HF366806 HF366699 HF366812 HF366700 HF366816 HF366701 HF366818 HF366706 HF366821 HF366707 HF366824 HF366708 HF366827 HF366714 HF366829 HF366717 HF366834 HF366718 HF366837 HF366719 HF366839 HF366720 HF366853 HF366722 HF366859 HF366723 HF366862 HF366724 HF366875 HF366732 HF366879 HF366733 HF366884 HF366734 HF366895 HF366735 HF366737

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.

device · product 4 of 4

RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component

Z-1790-2024
Recall number
Z-1790-2024
Initiated
March 25, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Ossur H / F
Quantity
1 unit

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
firmware issues with the prosthetic knee, there is the potential for unintended warnings and device shutdown which could result in

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI: 05690977467811/ Serial Number: HF363264

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.