| |
Class 2 Device Recall Power Knee with Power Knee Battery |
 |
| Date Initiated by Firm |
December 26, 2023 |
| Date Posted |
January 25, 2024 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0788-2024 |
| Recall Event ID |
93549 |
| Product Classification |
Assembly, knee/shank/ankle/foot, external - Product Code ISW
|
| Product |
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002 |
| Code Information |
REF/UDI-DI: PKA10001/05690967648381, PKA10003/05690967648749, PKA10002/05690967648404.
Knee/Battery Serial Numbers:
HF511036 HF551398,
HF511050 HF551935,
HF511065 HF552267,
HF511072 HF551258,
HF511081 HF552479,
HF511082 HF551327,
HF511084 HF552406,
HF511096 HF551301,
HF511098 HF551215,
HF511099 HF551366,
HF511104 HF551409,
HF511105 HF552404,
HF511119 HF551282,
HF511121 HF552298,
HF511122 HF551400,
HF511123 HF552314,
HF511124 HF552333,
HF511128 HF552414,
HF511130 HF552339,
HF511131 HF552315,
HF511132 HF552271,
HF511133 HF552268,
HF511136 HF552316,
HF511137 HF552332,
HF511138 HF552310,
HF511139 HF552483,
HF511142 HF552294,
HF511144 HF551368,
HF511148 HF552401,
HF511149 HF552317,
HF511150 HF552471,
HF511151 HF552251,
HF511163 HF552394,
HF511164 HF552311,
HF511165 HF552470,
HF511168 HF552326,
HF511169 HF551279,
HF511170 HF552309,
HF511171 HF552407,
HF511173 HF551477,
HF511178 HF552485,
HF511179 HF551344,
HF511181 HF552392,
HF511182 HF551347,
HF511183 HF551275/HF552399,
HF511185 HF552290,
HF511187 HF552331,
HF511188 HF552256,
HF511191 HF552249,
HF511192 HF552308,
HF511193 HF551346,
HF511194 HF552284,
HF511195 HF551216,
HF511198 HF552241,
HF511199 HF551321,
HF511200 HF552335,
HF511201 HF552260,
HF511242 HF551226,
HF511257 HF552327,
HF511267 HF552277,
HF511277 HF552305,
HF511278 HF552325,
HF511279 HF552245,
HF511280 HF552323,
HF511281 HF552255,
HF511282 HF552328,
HF511283 HF552296,
HF511293 HF551406,
HF511294 HF551380,
HF511295 HF552487,
HF511296 HF552408,
HF511298 HF551413,
HF511299 HF552299,
HF511302 HF551399,
HF511303 HF552264,
HF511306 HF551337,
HF511307 HF552337,
HF511308 HF552248,
HF511309 HF552340,
HF511311 HF552263,
HF511313 HF552307,
HF511314 HF552261,
HF511315 HF552478,
HF511318 HF552475,
HF511319 HF552280,
HF511320 HF552324,
HF511321 HF552312,
HF511322 HF552320,
HF511323 HF552259,
HF511325 HF551389,
HF511326 HF551218,
HF511327 HF551367,
HF511328 HF552301,
HF511339 HF552322,
HF511341 HF552286,
HF511342 HF552473,
HF511344 HF551527,
HF511345 HF551223,
HF511347 HF551271,
HF511348 HF552468,
HF511351 HF551219,
HF511355 HF552289,
HF511358 HF552275,
HF511360 HF551888,
HF511362 HF552476,
HF511364 HF552415,
HF511366 HF552472,
HF511367 HF552480,
HF511368 HF552490,
HF511369 HF552489,
HF511372 HF551837,
HF511373 HF552273,
HF511376 HF552395,
HF511381 HF551524,
HF511383 HF552269,
HF511384 HF551924,
HF511385 HF551372,
HF511388 HF552183,
HF511389 HF552398,
HF511390 HF551487,
HF511391 HF551681,
HF511392 HF552411,
HF511393 HF552170,
HF511394 HF551737,
HF511395 HF552179,
HF511396 HF551660,
HF511397 HF552182,
HF511398 HF551842,
HF511399 HF551553,
HF511400 HF552474,
HF511401 HF551952,
HF511403 HF551556,
HF511404 HF552272,
HF511406 HF552410,
HF511407 HF552293,
HF511408 HF551396,
HF511409 HF551908,
HF511410 HF552276,
HF511411 HF552412,
HF511412 HF552481,
HF511413 HF552409,
HF511416 HF551779,
HF511417 HF552229,
HF511418 HF552146,
HF511419 HF552173,
HF511420 HF551946,
HF511423 HF551937,
HF511424 HF551628,
HF511425 HF551696,
HF511426 HF552405,
HF511427 HF551533,
HF511428 HF552482,
HF511429 HF551558,
HF511430 HF552338,
HF511431 HF552318,
HF511432 HF551680,
HF511433 HF551543,
HF511434 HF551949,
HF511435 HF551727,
HF511436 HF551532,
HF511439 HF552363,
HF511440 HF551894,
HF511442 HF551671,
HF511444 HF551945,
HF511445 HF551522,
HF511450 HF551907,
HF511452 HF552469,
HF511454 HF551977,
HF511455 HF552288,
HF511456 HF551332,
HF511457 HF551343,
HF511458 HF552466,
HF511459 HF551928,
HF511460 HF551643,
HF511463 HF551933,
HF511464 HF551972,
HF511465 HF552043,
HF511466 HF551958,
HF511468 HF552300,
HF511469 HF552285,
HF511470 HF552413,
HF511471 HF551903,
HF511472 HF551904,
HF511473 HF551941,
HF511474 HF551943,
HF511475 HF551944,
HF511476 HF551947,
HF511477 HF551393,
HF511479 HF551905,
HF511482 HF551663,
HF511484 HF551898,
HF511485 HF551710,
HF511486 HF551987,
HF511488 HF551985,
HF511491 HF551959,
HF511492 HF551423,
HF511493 HF551980,
HF511495 HF551899,
HF511496 HF551983,
HF511500 HF552330,
HF511501 HF551979,
HF511502 HF551951,
HF511503 HF551916,
HF511504 HF551554,
HF511505 HF551700,
HF511506 HF551376/HF551971,
HF511507 HF551730,
HF511508 HF551518,
HF511509 HF551549,
HF511511 HF551550,
HF511513 HF551975,
HF511515 HF552391,
HF511516 HF551370,
HF511518 HF551954,
HF511519 HF552396,
HF511521 HF551653,
HF511523 HF551470,
HF511524 HF551545,
HF511526 HF551689,
HF511528 HF551531,
HF511532 HF551976,
HF511533 HF551965,
HF511534 HF551724,
HF511536 HF551564,
HF511538 HF551709,
HF511539 HF551546,
HF511540 HF552283,
HF511541 HF552265,
HF511542 HF551731,
HF511543 HF551843,
HF511545 HF551719,
HF511546 HF551541,
HF511548 HF552187,
HF511550 HF552166,
HF511551 HF552477,
HF511557 HF551751,
HF511558 HF552151,
HF511561 HF551896,
HF511562 HF552174,
HF511563 HF551565,
HF511565 HF551703,
HF511566 HF551953,
HF511567 HF551288,
HF511568 HF551350/HF551375,
HF511570 HF552188,
HF511574 HF551387/HF551957,
HF511575 HF552185,
HF511576 HF552141,
HF511579 HF552171,
HF511580 HF551642,
HF511581 HF551803,
HF511582 HF551539,
HF511585 HF551895/HF552291,
HF511587 HF551383/HF552175,
HF511589 HF551536,
HF511590 HF551902,
HF511591 HF551960,
HF511594 HF551544,
HF511595 HF552319,
HF511601 HF551317/HF551458,
HF511602 HF551658,
HF511603 HF551629,
HF511604 HF552148,
HF511605 HF551555,
HF511607 HF551750,
HF511613 HF551909,
HF511614 HF551560,
HF511616 HF552178,
HF511618 HF551887,
HF511623 HF551984,
HF511628 HF551884,
HF511630 HF551922,
HF511636 HF552254,
HF511638 HF551616,
HF511646 HF552361,
HF511653 HF551220/HF552257,
HF511655 HF552397,
HF511661 HF551940,
HF511662 HF551479,
HF511663 HF551363,
HF511664 HF552242,
HF511675 HF551233,
HF511681 HF551354,
HF511683 HF552364,
HF511697 HF551401,
HF511704 HF551306,
HF511706 HF551326,
HF511729 HF551437,
HF511735 HF551369,
HF511737 HF551440,
HF511740 HF551392,
HF511747 HF551237,
HF511748 HF551431,
HF511753 HF551385,
HF511755 HF552352,
HF511756 HF551478,
HF511757 HF551397,
HF511758 HF551434,
HF511759 HF551490,
HF511760 HF551230,
HF511761 HF551430,
HF511766 HF551426,
HF511768 HF551381,
HF511770 HF551447,
HF511771 HF551263,
HF511774 HF551488,
HF511775 HF552402,
HF511776 HF551265,
HF511777 HF552365,
HF511780 HF551231,
HF511781 HF551329,
HF511785 HF551342,
HF511786 HF551316,
HF511788 HF551351,
HF511789 HF551473,
HF511790 HF551408,
HF511794 HF551334/HF552329,
HF511795 HF551331,
HF511797 HF552356,
HF511801 HF551450,
HF511802 HF551474,
HF511807 HF552346,
HF511808 HF550808,
HF511810 HF551250,
HF511811 HF551248,
HF511812 HF551259,
HF511813 HF551323,
HF511816 HF551357,
HF511817 HF551217,
HF511818 HF551247/HF551673,
HF511819 HF551341,
HF511820 HF551462,
HF511821 HF551205,
HF511822 HF551302,
HF511824 HF551254,
HF511825 HF551333,
HF511826 HF551340,
HF511828 HF551269,
HF511829 HF551264,
HF511830 HF551419,
HF511831 HF551433,
HF511832 HF551460,
HF511835 HF551314,
HF511836 HF551438,
HF511838 HF551455,
HF511839 HF551362,
HF511847 HF551361,
HF511848 HF551436,
HF511849 HF551429,
HF511851 HF551241,
HF511852 HF551224,
HF511853 HF551255,
HF511858 HF551228,
HF511859 HF551336,
HF511860 HF551280,
HF511861 HF551234,
HF511864 HF551384,
HF511867 HF551442,
HF511868 HF552297,
HF511869 HF551466,
HF511870 HF551298,
HF511877 HF551421,
HF511878 HF551311,
HF511881 HF551287,
HF511883 HF551459,
HF511884 HF551374,
HF511885 HF551806,
HF511886 HF552357,
HF511888 HF551274,
HF511889 HF551266,
HF511890 HF551240,
HF511891 HF552347,
HF511892 HF551232,
HF511893 HF552304,
HF511900 HF551394,
HF511901 HF551428,
HF511902 HF551277,
HF511904 HF551355,
HF511905 HF551446,
HF511908 HF551348,
HF511909 HF551235,
HF511910 HF551296,
HF511913 HF551278,
HF511919 HF552295,
HF511920 HF551443,
HF511924 HF551481,
HF511925 HF551283,
HF511928 HF551273,
HF511930 HF551410,
HF511931 HF551427,
HF511932 HF551386,
HF511933 HF551449,
HF511935 HF551468,
HF511936 HF551483,
HF511938 HF551828,
HF511940 HF551319,
HF511948 HF551463,
HF511950 HF551771,
HF511951 HF551453,
HF511952 HF551244,
HF511953 HF551420,
HF511956 HF551467,
HF511957 HF551294,
HF511958 HF551339,
HF511959 HF551742,
HF511960 HF551284,
HF511961 HF551293,
HF511962 HF551412,
HF511966 HF552302,
HF511967 HF552342,
HF511969 HF551324,
HF511973 HF551252,
HF511974 HF552244,
HF511975 HF551246,
HF511976 HF551300,
HF511977 HF551295,
HF511981 HF552253,
HF511982 HF552243,
HF511984 HF551882,
HF511985 HF552246,
HF511986 HF551860,
HF511987 HF551289,
HF511988 HF552292,
HF511989 HF551461,
HF511990 HF551297,
HF511991 HF551793,
HF511993 HF551881,
HF511994 HF551320,
HF511997 HF551286,
HF512000 HF551451,
HF512001 HF551805,
HF512002 HF551418,
HF512003 HF552358,
HF512005 HF552341,
HF512006 HF551435,
HF512007 HF551464,
HF512008 HF551382,
HF512009 HF551270,
HF512010 HF551222,
HF512011 HF551785,
HF512012 HF551814,
HF512016 HF552282,
HF512018 HF551845,
HF512023 HF552252,
HF512024 HF551229,
HF512025 HF551870,
HF512027 HF551318,
HF512035 HF551886,
HF512036 HF551829,
HF512037 HF551847,
HF512038 HF552281,
HF512039 HF551746,
HF512040 HF551791,
HF512041 HF551448,
HF512042 HF551782,
HF512043 HF551800,
HF512047 HF551801,
HF512051 HF551753,
HF512052 HF551774,
HF512053 HF551865,
HF512054 HF551868,
HF512055 HF551749,
HF512056 HF551841,
HF512057 HF552486,
HF512058 HF551480/HF552250,
HF512060 HF551780,
HF512075 HF551880,
HF512076 HF551834,
HF512077 HF551879,
HF512081 HF551799,
HF512082 HF551811,
HF512085 HF551769,
HF512086 HF551858,
HF512090 HF551765,
HF512091 HF551863,
HF512092 HF551825,
HF512093 HF551862,
HF512094 HF551831,
HF512095 HF551822,
HF512096 HF551815,
HF512097 HF551358,
HF512098 HF551804,
HF512106 HF551773,
HF512109 HF551593,
HF512111 HF551826,
HF512112 HF551838,
HF512117 HF551827,
HF512121 HF551754,
HF512129 HF551652,
HF512130 HF551770,
HF512131 HF551963,
HF512132 HF551760,
HF512139 HF551646,
HF512146 HF551819,
HF512150 HF551654,
HF512151 HF551970,
HF512152 HF551650,
HF512154 HF551647,
HF512156 HF551649,
HF512157 HF551809,
HF512160 HF551969,
HF512161 HF551645,
HF512164 HF551636,
HF512165 HF551723,
HF512166 HF552228,
HF512167 HF551552,
HF512168 HF552222,
HF512170 HF551607,
HF512175 HF551624,
HF512176 HF551684,
HF512177 HF551725,
HF512178 HF552237,
HF512180 HF551722,
HF512181 HF551735,
HF512184 HF551755,
HF512186 HF551618,
HF512187 HF551752,
HF512188 HF551547,
HF512189 HF551885,
HF512190 HF551854,
HF512191 HF551761,
HF512192 HF551807,
HF512193 HF551633,
HF512198 HF551821,
HF512199 HF551718,
HF512203 HF551740,
HF512204 HF551929,
HF512207 HF551537,
HF512209 HF551677,
HF512210 HF551920,
HF512212 HF551925,
HF550746 HF551245,
HF551111 HF551414,
|
Recalling Firm/
Manufacturer |
Ossur H / F
Grjothals 5
Reykjavik Iceland
|
| For Additional Information Contact |
Joshua Portman
800-233-6263 Ext. 10
|
Manufacturer Reason
for Recall |
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
|
FDA Determined
Cause 2 |
Process control |
| Action |
On 12/26/23, recall notices were mailed to customers who were asked to do the following:
a. Check the serial number of the Power Knee Batteries to confirm the affected units.
b. Replace the affected batteries with the new batteries supplied along with this letter.
c. To ensure future traceability, please fit each new battery into the designated knee according to the knee Serial Number indicated on the sticker on the back of the battery.
d. PASS THIS NOTICE to those who need to be aware within your organization. If you have further distributed this product, please identify your customers, and notify them at once of this product alert. We recommend that you include a copy of this notice.
e. Complete and return acknowledgement forms and affected batteries in pre-paid return packaging provided.
Customers with questions can contact customer service at 1-800-233-6263, extension 10 |
| Quantity in Commerce |
544 Batteries |
| Distribution |
US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS.
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| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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