The OR Group,Inc.: Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

Recall number

Z-0953-03

Recalling firm

The OR Group,Inc.

Product

Allen Medical Systems PAL Pro Stirrups Catalog Number: A-10051-A1

Status

Terminated

Initiated

2003-06-02

Posted

2003-06-27

Terminated

2016-02-02

Reason

Foot Stirrups may detach from mount when user is locking system

Root cause

Other

Action

The OR Group notifed the accounts by letter sent Air Borne on 6/6/03 advising users to return the stirrups. The firm will inspect and repair the returned units. The firm expanded the recall to include units manufactured between August 02 and May 03. Recall letters were issued on 9/18/03 via Fed'X with instructions to test and identify the device for correct measurement.

Quantity

460 units

Distribution

Nationwide Foreign: Australia, Korea, Italy, Hong Kong, Ireland, Czech republic, South Africa,

Lot, serial or model codes

Serial Numbers-Domestic (424 units): A024096, A025850, A025851, A025852, A025853, A025854, A025855, A025856, A025857, A025858, A025859, A025946, A025947, A025948, A025949, A025950, A025951, A025952, A025953, A025966, A025967, A025968, A025969, A025970, A025971, A025972, A025973, A025974, A025975, A026140, A026141, A026142, A026143, A026144, A026145, A026146, A026147, A026148, A026149, A026370, A026371, A026372, A026373, A026374, A026375, A026376, A026377, A026378, A026379, A026515, A026516, A026517, A026518, A026519, A026520, A026521, A026522, A026523, A026524, A026624, A026625, A026626, A026627, A026628, A026629, A026630, A026631, A026632, A026633, A026694, A026695, A026777, A026778, A026779, A026780, A026781, A026782, A026783, A026784, A026785, A026786, A026787, A026788, A026789, A026790, A026791, A026792, A026793, A026794, A026795, A026796, A026800, A026801, A026934, A026935, A026936, A026937, A026938, A026939, A026940, A026941, A026942, A026943, A026957, A026958, A026959, A026960, A026961, A026962, A026963, A026964, A027061, A027062, A027063, A027064, A027065, A027066, A027067, A027068, A027069, A027070, A027121, A027122, A027123, A027124, A027125, A027126, A027127,  A027128, A027129, A027130, A027290, A027291, A027292, A027293, A027294, A027295, A027296, A027297, A027298, A027299, A027384, A027385, A027386, A027387, A027388, A027389, A027390, A027391, A027392, A027393, A027562, A027563, A027564, A027565, A027566, A027567, A027568, A027569, A027570, A027571, A027572, A027573, A027574, A027575, A027682, A027683, A027684, A027685, A027937, A027938, A027939, A027940, A027941, A027942, A027943, A027944, A027945, A027946, A028052, A028053, A028054, A028055, A028056, A028057, A028058, A028059, A028060, A028061, A028098, A028099, A028100, A028101, A028102, A028103, A028148, A028149, A028162, A028163, A028164, A028165, A028166, A028167, A028168, A028169, A028170, A028171, A028283, A028284, A028285, A028286, A028287, A028288, A028289, A028290, A028448, A028449, A028450, A028451, A028452, A028453, A028663, A028664, A028681, A028682, A028683, A028684, A028685, A028686, A028687, A028688, A028689, A028690, A028899, A028900, A028957, A028958, A028959, A028960, A028961, A028962, A028963, A028964, A028965, A028966, A028967, A028968, A028969, A028970, A028971, A028972, A028973, A028974, A028975, A028976, A029279, A029280, A029281, A029282, A029283, A029284, A029285, A029286, A029287, A029288, A029289, A029290, A029291, A029292, A029293, A029294, A029295, A029296, A029297, A029298, A029576, A029577, A029578, A029579, A029586, A029587, A029588, A029589, A029590, A029591, A029592, A029593, A029594, A029595, A029659, A029660, A029661, A029662, A029663, A029664, A029665, A029666, A029761, A029762, A029763, A029764, A029765, A029766, A029767, A029768, A029769, A029770, A029863, A029864, A029865, A029866, A029867, A029868, A029869, A029870, A029913, A029914, A029915, A029916, A029917, A029918, A029921, A029922, A029923, A029924, A029925, A029926, A029927, A029928, A030171, A030172, A030173, A030174, A030175, A030176, A030177, A030178, A030179, A030180, A030181, A030182, A030183, A030184, A030185, A030186, A030187, A030188, A030189, A030190, A030191, A030192, A030193, A030194, A030425, A030426, A030427, A030428, A030429, A030430, A030431, A030432, A030522, A030523, A030524, A030525, A030526, A030527, A030528, A030529, A030589, A030590, A030591, A030592, A030593, A030594, A030595, A030596, A030597, A030598, A030599, A030600, A030601, A030602, A030754, A030755, A030756, A030757, A030758, A030759, A030760, A030761, A030762, A030763, A030764, A030765, A030766, A030767, A030768, A030769, A030820, A031009, A031010, A031011, A031012, A031013, A031014, A031015, A031016, A031030, A031031, A031032, A031033, A031034, A031035, A031036, A031037, A031078, A031079, A031080, A031081, A031082, A031083, A031084, A031085. Serial Numbers Foreign (36 units):  206359, 206360, 206361, 206362, 209163, 209164, 209165, 209166, 209328, 209329, 209330, 209331, 210572, 210573, 211166, 211167, 212707, 212708, 213337, 213338, 214426, 214427, 215128, 215129, 215938, 215939, 217715, 217716, 218215, 218216, 218221, 218222, 219680, 219681, 222526, 222527.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FWZ

Firm FEI

not on file

Firm city

Acton

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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